Adherence to oral second-generation antipsychotic medications in patients with schizophrenia and bipolar disorder: physicians' perceptions of adherence vs. pharmacy claims.

OBJECTIVE: To compare physician-reported adherence of specific patients to oral second-generation antipsychotics vs. actual adherence rates determined from the patients' pharmacy claims. METHODS: Claims data from the HealthCore Integrated Research Database identified patients with schizophrenia or bipolar disorder with ≥ 1 oral second-generation antipsychotic prescription. The prescribing physicians were identified from the pharmacy claims and asked to complete an Internet survey assessing their perception of medication adherence for 1-2 of their patients and their beliefs regarding adherence to second-generation antipsychotics in general for a 1-year period. Adherence to second-generation antipsychotics was determined for each patient by pharmacy claims for the same period. Physician survey data were merged with patient claims data via unique patient identifiers, and physician-reported adherence rates were compared with claims-based rates as measured by the medication possession ratio. RESULTS: One hundred and fifty-three physicians responded to the survey, representing 214 patients (44 with claims for schizophrenia, 162 with bipolar disorder, 8 with claims for bipolar disorder and schizophrenia). Most physicians (60%) had no formal adherence training. More than two-thirds (68%) reported emphasising the importance of adherence and reported approximately 76% of their patients were adherent (≥ 71% of the time). In the schizophrenia group, 16 of 17 (94%) patients with low-to-moderate (≤ 70%) adherence levels had high (≥ 71%) physician-estimated adherence. In the bipolar disorder group, 62 of 92 (67%) patients with low-to-moderate adherence levels had high physician-estimated adherence. CONCLUSIONS/INTERPRETATION: These analyses suggest that, even when physicians are asked about specific patients in their practice, there is discordance between physician perceptions and adherence as measured through pharmacy claims. This disparity may delay appropriate interventions, potentially contributing to relapses.

Exploratory analysis of psychiatric-related utilization and costs associated with paliperidone ER compared with other oral atypical antipsychotics using pharmacy claims from an administrative database.

OBJECTIVE: To compare psychiatric-related healthcare resource utilization (inpatient facility admissions, emergency room visits and ambulatory visits) and costs (medical, pharmacy and total healthcare costs) in patients initiated on paliperidone extended release (ER), risperidone, aripiprazole, olanzapine, ziprasidone or quetiapine. METHODS: This exploratory, retrospective administrative claims analysis database compared patients from a large US commercial health plan who were initiated on their index oral atypical antipsychotics between January 1, 2007, and June 30, 2007. Cohorts were assigned by first antipsychotic claim and propensity score-matched by age, gender, US census division, race, household income, baseline antipsychotic use, co-morbid conditions and psychiatric-related utilization. Psychiatric-related healthcare resource utilization and costs were measured for 6 months post-initiation. Descriptive analyses compared paliperidone ER with the other cohorts. RESULTS: There were 562 patients in matched paliperidone ER (n = 95), risperidone (n = 94), aripiprazole (n = 94), olanzapine (n = 89), ziprasidone (n = 95) or quetiapine (n = 95) cohorts. The paliperidone ER cohort had fewer mean psychiatric-related ambulatory visits than the risperidone cohort (p = 0.05). The paliperidone ER cohort had significantly lower mean psychiatric-related medical costs than the olanzapine, quetiapine and ziprasidone cohorts (p < 0.05) and lower total costs than the ziprasidone and olanzapine cohorts (p = 0.02). No other outcomes were significantly different. LIMITATIONS: Small sample sizes and short post-index observation times due to the launch of paliperidone ER in January 2007, coupled with the inherent lag time with medical claims data, limit the generalizability of the study findings. CONCLUSION: Patients treated with paliperidone ER may have psychiatric-related utilization costs that are comparable to those of patients who initiated treatment with other oral atypical antipsychotics.

Shame and guilt and their relationship to positive expectations and anger expressiveness.

College students (174 females, 91 males) completed measures of shame, guilt, expectations for future success, and styles of anger expression. Significant gender differences were found in proneness for both shame and guilt, with young women exhibiting a greater propensity for shame and guilt than young men. For both females and males, however, shame-proneness was positively related to expressions of inward anger. Among males and females, guilt-proness was negatively related to outward anger, but positively related to anger control. For females, guilt-proness was also negatively related to expectations for future success. Multiple regression analyses indicated that for male and female late adolescents, the best positive predictor of shame-proneness was inward anger. Gender differences emerged in predicting guilt-proneness; greater anger control, lower outward anger, and lower expectations for future success significantly predicted this variable among females.

Risk of colorectal cancer in the families of patients with adenomatous polyps. National Polyp Study Workgroup.

BACKGROUND: The adenoma-adenocarcinoma sequence in colorectal cancer suggests an increased risk of colorectal cancer in the families of patients with adenomatous polyps. METHODS: A random sample of participants in the National Polyp Study who had newly diagnosed adenomatous polyps were interviewed for information on the history of colorectal cancer in their parents and siblings. The risk of colorectal cancer in family members was analyzed according to the characteristics of the patients with adenomas and in comparison with a sample of patients' spouses, who served as controls. RESULTS: Among the patients with adenomas, 1199 provided information on whether they had a family history of colorectal cancer. After the exclusion of families for which information was incomplete and of 48 patients who had been referred for colonoscopy solely because they had a family history of colorectal cancer, there were 1031 patients with adenomas, 1865 parents, 2381 siblings, and 1411 spouse controls. The relative risk of colorectal cancer, adjusted for the year of birth and sex, was 1.78 for the parents and siblings of the patients with adenomas as compared with the spouse controls (95 percent confidence interval, 1.18 to 2.67). The relative risk for siblings of patients in whom adenomas were diagnosed before 60 years of age was 2.59 (95 percent confidence interval, 1.46 to 4.58) as compared with the siblings of patients who were 60 or older at the time of diagnosis and after adjustment for the sibling's year of birth and sex and a parental history of colorectal cancer. The risk increased with decreasing age at the time of the diagnosis of adenoma (P for trend < 0.001). The relative risk for the siblings of patients who had a parent with colorectal cancer, as compared with those who had no parent with cancer, was 3.25 (95 percent confidence interval, 1.92 to 5.52), after adjustment for the sibling's year of birth and sex and the patient's age at diagnosis. CONCLUSIONS: Siblings and parents of patients with adenomatous polyps are at increased risk for colorectal cancer, particularly when the adenoma is diagnosed before the age of 60 or--in the case of siblings--when a parent has had colorectal cancer.

Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup.

BACKGROUND: The current practice of removing adenomatous polyps of the colon and rectum is based on the belief that this will prevent colorectal cancer. To address the hypothesis that colonoscopic polypectomy reduces the incidence of colorectal cancer, we analyzed the results of the National Polyp Study with reference to other published results. METHODS: The study cohort consisted of 1418 patients who had a complete colonoscopy during which one or more adenomas of the colon or rectum were removed. The patients subsequently underwent periodic colonoscopy during an average follow-up of 5.9 years, and the incidence of colorectal cancer was ascertained. The incidence rate of colorectal cancer was compared with that in three reference groups, including two cohorts in which colonic polyps were not removed and one general-population registry, after adjustment for sex, age, and polyp size. RESULTS: Ninety-seven percent of the patients were followed clinically for a total of 8401 person-years, and 80 percent returned for one or more of their scheduled colonoscopies. Five asymptomatic early-stage colorectal cancers (malignant polyps) were detected by colonoscopy (three at three years, one at six years, and one at seven years). No symptomatic cancers were detected. The numbers of colorectal cancers expected on the basis of the rates in the three reference groups were 48.3, 43.4, and 20.7, for reductions in the incidence of colorectal cancer of 90, 88, and 76 percent, respectively (P < 0.001). CONCLUSIONS: Colonoscopic polypectomy resulted in a lower-than-expected incidence of colorectal cancer. These results support the view that colorectal adenomas progress to adenocarcinomas, as well as the current practice of searching for and removing adenomatous polyps to prevent colorectal cancer.

The National Polyp Study. Design, methods, and characteristics of patients with newly diagnosed polyps. The National Polyp Study Workgroup.

The National Polyp Study (NPS) is a multicenter prospective randomized trial designed to evaluate follow-up surveillance strategies in patients who have undergone polypectomy for the control of large bowel cancer. The study design was developed by a joint research committee from American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and the American College of Gastroenterology. Subjects who met the eligibility criteria were randomized into two different treatment arms. Eligibility criteria included: removal of one or more adenomas; complete colonoscopy; no prior polypectomy, inflammatory bowel disease, or familial polyposis; and no history of colon cancer. The treatment arms consisted of a frequent follow-up (1 and 3 years after initial polypectomy) and a less frequent follow-up (3 years). Follow-up examinations included fecal occult blood tests, air-contrast barium enema, and colonoscopy. The latter was done on 9112 referred patients at the seven participating centers from November 1980 until February 1990 who had no history of polypectomy, colon cancer, familial polyposis, or inflammatory bowel disease. Of these patients, 4763 (52.3%) had no polyps; 549 (6.0%) had an invasive cancer; 776 (8.5%) had nonadenomatous polyps; 208 (2.3%) had incomplete examinations; 184 (2.0%) had other findings; and 2632 (28.9%) had one or more adenomas, of which 1418 (53.9%) were randomized to one of the two treatment arms. This article reports the background, rationale, objectives, methods, and organization of this study and includes patient characteristics on initial presentation. Future data provided by the NPS may help in the development of recommendations for surveillance guidelines for such patients. This study also provides a framework to address questions regarding the natural history of adenomas and their relationship with colorectal cancer.

Familial empiric risk estimates of inflammatory bowel disease in Ashkenazi Jews.

Genetic factors have been implicated in the etiology of inflammatory bowel disease (IBD) because of the increased occurrence of IBD in relatives. To further characterize the familial aggregation of IBD, we obtained family histories by interview on 188 IBD patients, including 154 Ashkenazi Jews (82%), ascertained through a Los Angeles gastroenterology practice. Thirty-three index cases (17.6%) had at least one affected first-degree relative; an additional 11 had more distant affected relatives. Thus, 23.4% of our sample had a positive family history. The quantification of empiric risk estimates for various classes of relatives has been quite limited and has been reported in only a few series. An important goal of our study was the determination of the specific empiric risk figures for relatives. We obtained uncorrected risk estimates of 2.5% to off-spring, 5.2% to siblings, and 2.9% to parents. Although the highest risk we observed is to siblings, IBD has a variable and often late age of onset, and it is likely that many relatives, particularly offspring, of patients in this sample have not reached the age at which they will manifest clinical disease. Thus, these uncorrected risks as well as those reported in the literature are an underestimate of the true empiric risks. To provide an estimate of the true lifetime risks, we utilized age-specific incidence data to calculate the following age-corrected empiric risk estimates for IBD: 8.9% to offspring, 8.8% to siblings, and 3.5% to parents. It is these latter age-corrected estimates that are most appropriate for both genetic counseling and genetic modeling.

Hemobilia: endoscopic diagnosis and association with pancreatitis.

Hemorrhage into the biliary tract, known as hemobilia, is discussed almost exclusively in the surgical literature. Internists should also be aware of this entity. Two cases of hemobilia from hepatic artery aneurysm that ruptured into the biliary tract are presented. Both patients developed pancreatitis in addition to the classic symptom triad of melena, right upper quadrant pain, and jaundice. In one paitent, hemobilia was established by endoscopy. The authors adivse endoscopy workup of such patients and emphasize that pancreatitis, secondary to pancreatic duct obstruction, may be more common with hemobilia than has been reported.

BCG treatment of Crohn's disease.

Among 53 patients with documented Crohn's disease, 30% manifested a defect in delayed hypersensitivity demonstrated by negative DNCB skin tests and significant (p less than 0.01) T-lymphocyte hyporeactivity. A double-blind controlled trial was conducted to evaluate oral Bacillus Calmette-Guerin (BCG) therapy in nine of these patients with Crohn's disease and deficient cellular immunity. All patients had a Crohn's Disease Activity Index (CDAI) greater than 150 (at least moderate activity) upon randomization to BCG (five patients) or placebo (four patients) treatment for six to 12 months. No significicant differences between BCG and placebo treatment were found in the CDAI, laboratory tests and gastrointestinal roentgenograms. We conclude that the disturbance in cell-mediated immunity in patients with Crohn's disease probably is a manifestation of the disease rather than an etiological factor and that immunostimulation with oral BCG is not effective therapy.

Gallstones.

Cholesterol saturation of bile has a primary role in the pathogenesis of gallstone formation. Predisposing factors should be considered. The characteristic features of biliary colic are important to keep in mind, as well as the fact that a history of fatty food intolerance is not of value in the diagnosis of gallstones. The technique of endoscopic retrograde cholangiography is useful for the diagnosis of bile duct stones in jaundiced patients and in patients with a strong clinical history, but in whom findings on oral and intravenous cholangiograms are within normal limits. Improved techniques of operative cholangiography to diminish the incidence of retained gallstones have been developed. Also, choledochoscopy provides a remarkable technique for diagnosis and choledocholithotomy. The dissolution of gallstones with chenodeoxycholic acid is an experimental procedure. This bile acid is thought to act by increasing the chenodeoxycholic acid pool size and decreasing cholesterol synthesis and secretion, thereby reversing the defects responsible for gallstone formation.