Comparative effectiveness and safety of infliximab and adalimumab in patients with ulcerative colitis.

BACKGROUND: Real-world comparative benefits and risks of infliximab (IFX) and adalimumab (ADA) in patients with ulcerative colitis (UC) are unclear. AIM: To evaluate the comparative effectiveness and safety of IFX and ADA in patients with UC who were new users of anti-TNF agents. METHODS: Using an administrative claims database (Optum Labs Data Warehouse), we identified patients who received first anti-TNF (IFX, ADA) prescription after a 12-month period without any anti-TNF treatment (baseline), and with a minimum 6-month follow-up after anti-TNF initiation. Primary outcome measures were: all-cause and UC-related hospitalisation, abdominal surgery, corticosteroid use >60 days after starting anti-TNF, and serious infections. We performed 2:1 propensity-score matched Cox proportional hazard analysis, and inverse probability-of-treatment weight (IPTW) analysis, accounting for healthcare utilisation, comorbidities and use of UC-related medication. RESULTS: We included 1400 new users of anti-TNF agents (age, 43 ± 15 years; 52% males), from 2006 to 2014. On propensity-score matched analysis, there was no significant difference in the risk of UC-related hospitalisation [IFX vs. ADA; adjusted hazard ratio (aHR), 1.04; 95% confidence interval (CI) 0.71-1.51], corticosteroid use (aHR, 0.85; 95% CI, 0.68-1.06) and serious infections (aHR, 0.62; 95% CI, 0.29-1.34) between IFX- and ADA-treated patients; the number of surgical events was very small. On IPTW analysis, risk of corticosteroid use was significantly lower in IFX - as compared to ADA - treated patients (aHR, 0.82; 95% CI, 0.68-0.99). Results were stable on multiple sensitivity analyses. CONCLUSIONS: In a large retrospective cohort of patients with UC who were new users of anti-TNF agents, IFX-treated patients may have lower corticosteroid use than ADA-treated patients, but risk of hospitalisation and serious infections were comparable.

Increased risk of herpes zoster among 108 604 patients with inflammatory bowel disease.

BACKGROUND: Patients with inflammatory bowel disease (IBD) on certain immunosuppressants have increased herpes zoster (HZ) risk. AIM: To determine the risk of HZ in IBD and how antitumour necrosis factor-alpha (anti-TNF) agents affect this risk. METHODS: We performed a retrospective cohort and nested case-control study using administrative data from IMS LifeLink(®) Information Assets-Health Plan Claims Database. In the cohort, we identified IBD patients

Computer databases of medical school curricula.

As the pace of curriculum reform in medical education has accelerated during the past decade, so too have demands on curriculum managers to supply increasingly detailed information about the curriculum. In response, a number of schools have joined together to begin work on designs for computer databases of the curriculum. The authors describe three of the most mature curriculum database prototypes, developed by groups at the medical schools of the University of North Carolina at Chapel Hill (UNC), The University of Maryland, and the University of Miami. All three groups have employed relational database management systems to organize information about each "instructional unit" in the preclinical curriculum, including a set of keywords defining the major concepts presented. The keywords are indexed to a controlled vocabulary, either the Medical Subject Headings (MeSH) or a MeSH derivative. The UNC database also employs a textfile management system to provide users with an overview of the entire curriculum. Future work will focus on identifying a suitable controlled vocabulary; capturing content in greater contextual detail; incorporating alternative learning formats, such as problem-based learning; creating links between content items and examination questions; and capturing information generated by student-patient interactions in clinical settings. As a result of recent collaboration with the Association of American Medical Colleges, work to define a prototype national database has begun and a consortium of interested schools is addressing further development activities.

The impact of school-based education on the young child's understanding of death.

The young child's immature understanding of the concepts related to death serves to heighten anxiety about death and interferes with successful adjustment to loss. This study was a randomized trial of the efficacy of a 3-week school-based educational program in the promotion of the concepts of death in 4- to 8-year-old children (prekindergarten through second grade). The Smilansky Death Concept Questionnaire, a validated and published structured interview, was administered pre- and postintervention phase to all study participants (N = 184). The experimental group received three interventions: (1) a series of six 30 to 45-minute presentations about concepts of death, (2) teacher educational presentation, and (3) parent educational presentation. Significant mean gains were noted for the experimental group as compared to the control group in the total death concept score, the total score for human death, the total score for animal death, and two of the four factors studied, that of causality and that of inevitability and old age. The gain in total death concept score as a result of the 3-week educational program was equivalent to the amount of conceptual development that is seen in one year in the absence of intervention.

The Pediatric Early Elementary Examination: sensitivity and specificity.

Evaluated the sensitivity and specificity of the Pediatric Early Elementary Examination (PEEX), a test designed to identify children at risk for learning problems. Using a sample of 299 seven- to nine-year-old "disadvantaged" children, the number of "areas of concern" identified by the PEEX and a school record indicating whether a child was receiving special educational services were used to compute test sensitivity and specificity. For two areas of concern, the sensitivity was 76.9% and specificity was 59.9%. The findings indicate that the PEEX correctly identified only 64.3% of children receiving special educational services. The test has a high rate of false positives while still failing to identify 6-7.5% of the children receiving special education services. Other issues relating to the utility of the PEEX are discussed.

Dark adaptation in hyperprolactinemic women.

In a study to test the hypothesis that hyperprolactinemia is caused by subclinical zinc deficiency, dark-adaptation curves of seven women with primary hyperprolactinemia and seven normal women were measured to assess tissue zinc status. Although plasma zinc levels, final dark-adapted thresholds, and the time courses of rod dark-adaptation did not differ significantly between patients and normal subjects, the median cone plateau of the hyperprolactinemic patients was significantly higher (0.66 log units) than that of normal subjects. It appears unlikely that derangements of vitamin A metabolism, for which zinc is a cofactor, explains this unanticipated and subtle abnormality in dark adaptation of the hyperprolactinemic women.

Evaluation of a self-instructional method for improving doctor-patient communication.

The purpose of the project reported here was to develop and evaluate an educational intervention to improve the interviewing skills learned in medical school. Sixty fourth-year medical students in a required ambulatory care rotation were randomly selected and randomly assigned to one of four conditions. All students interviewed a simulated patient who presented with one of five main complaints, and the interview was videotaped. Students were assigned to a control group or to one of three intervention groups: viewing a self-instruction videotape, viewing and critiquing a videotape of their interview, or both of these activities. The students assigned to the control group did not participate in any educational interventions. At the end of the intervention period, the students again interviewed a simulated patient and were videotaped. The 120 videotaped interviews were reliably rated by a scoring system developed by the project team. The postintervention interviews conducted by students in the two groups that used the self-instruction videotape received significantly higher ratings than those in the control group. These results suggest that this self-instruction intervention can improve the interviewing skills of senior medical students.

An assessment of entering freshman medical students' knowledge of and attitudes toward AIDS.

The purpose of this survey was to determine entering freshman medical student awareness of and attitudes toward AIDS. It is encouraging to find that, in general, students are well informed about AIDS before entering medical school; they have very real concerns about the possibility of contracting AIDS themselves as future care givers; and that they, in the final analysis, will consent to function as care givers to patients who have or may have AIDS while assuming responsibility to take appropriate precautions. It is important to stress that this survey reflects the pre-formed attitudes of entering freshman medical students. The University of Maryland School of Medicine is actively involved with the integration of AIDS education officially into the medical school curriculum. The results of this survey highlight the need for the inclusion of learning experiences designed to enhance physician/patient interaction skills when administering care to AIDS patients. It is believed that the acquisition of these desirable skills will generalize to better quality care for all patients. It is planned to administer the HIV/AIDS Questionnaire in a follow-up study to graduating seniors to assess their knowledge and attitudes toward AIDS. This will permit a comparison of attitude change among medical students, and an evaluation of newly implemented curricular changes.

Choledochoscopy in prevention of retained common bile duct stones.

More than 150,000 patients undergo exploration of the common bile duct each year in the United States, and approximately 10 per cent of these patients are later found to have retained common bile duct stones. The usual recommended procedure to decrease the incidence of retained calculi is a more complete exploration of the common duct at time of initial operation. It is thought that the incidence of retained common bile duct stones can be decreased and almost eliminated with proper use of the flexible choledochoscope following intraoperative cystic duct cholangiogram. The technical aspects of choledochoscopy are reviewed and experience with its use in 102 cases between July 1978 and October 1985 is reported. There were no residual stones in the span of the study using the flexible choledochoscope as a routine procedure in common bile duct exploration.

Routine intraoperative cholangiogram.

The value of a routine intraoperative cholangiogram is controversial. We reviewed 352 consecutive instances of cholecystectomy for nonmalignant disease during a period of three years to assess the diagnostic accuracy and additional cost of the roentgenographic technique. Intraoperative cholangiogram was done in all except 11 patients. Forty-nine of 341 patients underwent exploration of the common bile duct. The diagnosis was determined by the cholangiogram and was correct in 46 patients with three false-positive results. The other 292 patients did well without exploration of the common bile duct. The cholangiocatheter and a special cholangioclamp made the procedure easy and minimized additional operation time (five minutes with no mortality and negligible morbidity). Clinical indications for exploration of the common bile duct correlated poorly with abnormal findings in the bile duct. Unsuspected common duct stones were detected by cholangiogram in 17 (5 per cent) patients. Possible iatrogenic trauma to the common duct was prevented when significant abnormal findings were demonstrated by cholangiogram. The results of this study indicate that routine intraoperative cholangiogram is: accurate for diagnosis of common bile duct stones; useful in identification of bile duct anomalies and, thus, aids in preventing injury to the common bile duct; safe with negligible risk, and neither expensive nor time consuming if done correctly as a routine procedure.

The value of the California Psychological Inventory in predicting medical students' career choice.

Much of the research in medical education has focused on the prediction of medical students' future career choices. This longitudinal study evaluates the effectiveness of the California Psychological Inventory (CPI) in predicting career choices of students attending the University of Maryland School of Medicine. While results did reveal some significant and consistent differences between career choice groups, these differences were not of the magnitude to allow discrimination among all specialty groups. There is no evidence to support the hypothesis that career choice can be predicted from CPI data. It was concluded that future research into career choice prediction should focus on variables other than personality characteristics as measured by the CPI or similar tests.

A model for peer tutoring in the medical school setting.

For the past several years, the University of Maryland School of Medicine has operated a successful and efficient basic science peer tutorial program through the management of the Office of Medical Education. During the 1981-82 and 1982-83 academic years, 122 tutoring dyads were formed to take advantage of the tutoring program in nine of the 10 basic science courses encountered during the first two years of medical training. The success of the program is evident in that tutored students received passing grades in 102 (84 percent) of the courses in which they were tutored. In this paper, the authors discuss the systematic procedure of managing a peer tutorial program and the potential positive effects the program has on student tutors as well as on the medical student in academic difficulty.

Developing a cancer prevention elective course.

A comprehensive course on cancer prevention was developed for medical students at the University of Maryland School of Medicine. This course was developed under a three-year contract with the National Cancer Institute during the period from 1979 to 1982. The course development team was multidisciplinary and consisted of faculty members from the departments of pathology, epidemiology and preventive medicine, and family medicine and the Office of Medical Education. The finished course consisted of 20 instructional modules which can be used individually, in groups, or as a complete course in cancer prevention. During the developmental process, all educational objectives were subjected to intensive review and critique by faculty members from the University of Maryland School of Medicine and several other medical schools. The course was pilot tested as a four-week "minimester" elective, revised, and field tested again. This innovative, multidisciplinary, modular curriculum package is now considered complete and appropriate for use by other health sciences institutions.

The impact of external examinations on medical education programs and students.

The use of externally produced comprehensive examinations by medical schools as assessment instruments for promotion and as mechanisms for curricular evaluation is discussed and assessed for validity in this article. The pros and cons of the development of a single route to licensure by an externally produced series of comprehensive examinations are examined, and potential effects that emphasis on external examinations may have on students' psychological and ethical behavior are discussed. Recommendations for development of a national library test bank are proposed as alternatives to the current dependency on the externally produced comprehensive examinations. The necessity for each individual medical school to validate any external examination being used as an evaluation tool of the school's specific curriculum is stressed. The author recommends criterion-referencing as an appropriate mechanism for test construction and grading and that "passing" an externally produced comprehensive examination be defined in terms of basic minimal competency levels.