Impact of multiple comparisons in randomized clinical trials.

The randomized clinical trial is the preferred research design for evaluating competing diagnostic and therapeutic alternatives, but confidence in the conclusions from a randomized clinical trial depends on the authors' attention to acknowledged methodologic and statistical standards. This survey assessed the level of attention to the problem of multiple comparisons in the analyses of contemporary randomized clinical trials. Of the 67 trials surveyed, 66 (99 percent) performed multiple comparisons with a mean of 30 therapeutic comparisons per trial. When criteria for statistical impairment were applied, 50 trials (75 percent) had the statistical significance of at least one comparison impaired by the problem of multiple comparisons, and 15 (22 percent) had the statistical significance of all comparisons impaired by the problem of multiple comparisons. Although some statistical techniques are available, there still exists a great need for future work to clarify further the problem of multiple comparisons and determine how the impact of this problem can best be minimized in subsequent research.

Lack of association between medication use and the presence or absence of bacteriuria in elderly women.

This study was undertaken to determine if there is an association between medication use and the presence or absence of bacteriuria in elderly ambulatory women. Of 198 women who participated in three urine culture surveys (every 6 months) during the 18-month study period, 66 (34.4%) had bacteriuria on at least one survey. Both univariate and multivariate analyses for the demographics, age, place of residence, and medication use (by drug class) revealed that only place of residence had a significant association with the presence or absence of bacteriuria. In this regard, bacteriuric subjects more commonly resided in the nursing home and less commonly lived in the apartment-house complex compared with nonbacteriuric subjects (P less than .05). Therefore, this study demonstrates that in elderly ambulatory women, medication use does not appear to be associated with the presence or absence of bacteriuria.

Comparison of simulated patient and didactic methods of teaching HIV risk assessment to medical residents.

INTRODUCTION: Physicians need to be well trained in HIV risk assessment interview skills. Little has been written in the literature concerning training methods for this specialized interview. METHODS: One model to teach the HIV risk assessment interview has been developed and has been used to teach third-year medical students. We compared this interactive model, which uses simulated patients to teach HIV Risk Assessment, to a didactic one. Twelve medical residents were taken through either the interactive session or the didactic session. Pre-post changes from questionnaires were calculated to determine any differences in sessions. Also, Objective Structured Clinical Examinations (OSCEs) were used to grade all residents 2 weeks after their sessions. RESULTS: All pre-post changes were calculated and no statistically significant differences were seen (P > 0.50). OSCE interpersonal skills scores and content scores were calculated. The interactive group had statistically significantly higher scores (P < 0.05). CONCLUSION: The data supports the conclusion that an interactive method is more effective to use to train HIV risk assessment interview skills to medical residents when compared to the didactic method.

Survival of Burkholderia cepacia on environmental surfaces.

Burkholderia (Pseudomonas) cepacia is an important pathogen amongst persons with cystic fibrosis (CF), and evidence suggests that transmission of strains within CF clinics contributes to pulmonary colonization of some patients. In order to optimize preventive strategies, the survival of B. cepacia on various environmental surfaces, including cotton cloth, stainless steel, latex and polyvinylchloride (PVC) tubing, was investigated. For surface inoculation, bacteria were suspended in phosphate buffered saline, sputum from CF patients, or sputum from persons without CF. The results demonstrate that amongst the strains examined, organisms survived significantly (P < 0.001) longer when suspended in sputum from CF patients than in either non-CF sputum or buffered saline. Significant (P < 0.001) differences in survival on the various surfaces were found; survival was greatest on PVC. Significant (P < 0.001) strain-to-strain differences in survival were also demonstrated; patient isolates representing predominant CF centre ribotypes survived longest. These data demonstrate that (1) B. cepacia can survive for long periods in respiratory droplets on environmental surfaces typically found in CF clinics, (2) undefined factors in sputum from patients with CF may contribute to survival of B. cepacia, and (3) strain-to-strain variation in survival time may affect strain transmissibility.

Impact of a standardized patient intervention to teach breast and abdominal examination skills to third-year medical students at two institutions.

BACKGROUND: This study examined whether a single intervention with standardized patients (SPs) as a supplement to traditional teaching during the surgery clerkship would enhance the breast and abdominal examination skills of third-year medical students. METHODS: During the academic year 1994-1995, 153 students from two institutions were assigned to control or experimental groups. At institution A, all students underwent pretests and posttests with SPs; at institution B, no pretest was conducted. All experimental students received group and one-to-one instruction with SPs during the intervention session. RESULTS: At posttest, the experimental group performed better than the control group on breast examination (P = 0.002), professionalism during this examination (P <0.001), abdominal examination (P <0.001), and professionalism during the latter examination (P = 0.050). The improvement from pretest to posttest at institution A was significantly greater in the experimental group than the control group for the breast examination (P = 0.036) and the abdominal examination (P <0.001). Analyses on a variety of specific tasks within each examination were also performed. CONCLUSION: A single intervention with SPs teaching breast and abdominal examinations resulted in significant enhancement of these clinical skills.

Advantage of high-surface-area charcoal for gastrointestinal decontamination in a human acetaminophen ingestion model.

OBJECTIVE: To compare the abilities of low-surface-area (LSA) vs 2 types of high-surface-area (HSA) activated charcoal given orally to adsorb acetaminophen in the gastrointestinal (GI) tract, as demonstrated by the impact of these agents on the serum levels and area under the curve (AUC) in a simulated human overdose model. METHODS: The main arm of the study was a prospective double-blind crossover trial in which 6 volunteers, serving as their own controls, ingested acetaminophen (50 mg/kg), followed randomly in 10 minutes by either powdered LSA charcoal (950 m2/g) or powdered HSA charcoal (2,000 m2/g) in a charcoal:drug ratio of 8:1. In a second arm of the study, 3 subjects additionally ingested an equal dose of a granular preparation of the HSA charcoal. Serial serum acetaminophen levels were analyzed at various intervals (30, 60, 90, 120, 180, 240, and 300 minutes postingestion), and a 5-hour AUC was calculated. The subjects also rated the charcoal preparations for palatability. RESULTS: Serum acetaminophen levels were lower at all measured times in the groups receiving both forms of the HSA charcoal vs the LSA product. With the powdered HSA charcoal, comparison serum levels were significantly lower at 120 minutes postingestion and all times thereafter (p < 0.05), reaching high significance at 4 and 5 hours (p < 0.001). The subjects receiving the granular HSA charcoal also had consistently lower serum acetaminophen levels than did those receiving the LSA product, and the difference in mean serum levels was significant at the 4- and 5-hour sample (p = 0.012). Compared with the LSA charcoal, at the 4-hour postingestion sample, serum acetaminophen levels were reduced by 44% to 85% by the powdered HSA charcoal. The total AUC for the 5-hour study period was also significantly reduced by the powdered HSA product (p = 0.005) and the granular HSA product (p = 0.043). All the subjects rated the powdered HSA charcoal to be more palatable and easier to drink than the powdered LSA charcoal. CONCLUSION: The surface area of oral activated charcoal is a major determining factor in its ability to limit acetaminophen absorption and to fulfill its adsorptive role in GI decontamination. In a human acetaminophen overdose model, 2 types of HSA charcoal, when compared with equal doses of LSA charcoal, significantly reduced serum levels and total acetaminophen absorption as measured by the AUC.

Selecting a rating scale for evaluating services to the chronically mentally ill.

A multi-attribute utility analysis employing ideal outcome measure criteria was applied to seven brief rating scales in order to identify the best performing instrument. A variety of judgmental data were collected from therapists working in mental health service agencies and from evaluation research experts to contrast the performance of the seven rating scales on criteria for selecting outcome measures developed by an NIMH task force. Transformations of the performance data were weighted in accordance with priorities assigned to the criteria by the task force. Comparing the sums of the weighted scores across scales, two rating scales emerged as preferred selections for monitoring the effectiveness of programs that serve the chronically mentally ill.

Where nontradition is the norm: are sex and age determinants of practicing primary care specialties?

We studied the gender, age at graduation, and specialty of 2329 graduates of The Medical College of Pennsylvania (MCP) to determine if women and older graduates of a historically female institution tend to practice primary care specialties. Four of the primary care specialties studied, obstetrics and gynecology, family practice, general internal medicine, and pediatrics, are actively engaged in promoting women's health. MCP graduates were selected for study because of the institution's commitment to women's health and its association with admitting qualified, nontraditional students whose gender and age may have inhibited acceptance elsewhere. Seventy-two percent (1672) of the 1970-1992 graduates responded to an alumnae/i questionnaire. Chi-square tests revealed that female graduates were more likely to practice family practice, pediatrics, and obstetrics-gynecology but not more likely to practice general internal medicine. There was no relationship between age and practicing any of the four specialties. As more females graduate from U.S. medical schools, it is likely that they will retain their tendency to practice primary care specialties. These specialties offer women the opportunity to practice various aspects of comprehensive, lifelong women's healthcare. We should not expect older graduates schooled in environments favorable to women's health and careers to practice primary care medicine.

Psychological distress in cancer patients and their spouses.

The degree of psychosocial distress experienced by 15 cancer patients with newly diagnosed metastatic disease and their spouses was investigated. Of interest were mean changes over the six-month interval following diagnosis, and correlations between partners at 0, 3, and 6-7 months. The Psychosocial Adjustment to Illness Scale (PAIS) and the Family Environment Scale (FES) were used to quantify adjustment. Several PAIS subscales exhibited increasing distress over time for patients: Social Environment (p = 0.004), Vocational Environment (p = 0.028), and Psychological Distress (p = 0.029). FES Conflict increased over time (p < 0.005), while Intellectual Cultural Orientation declined (p = 0.02), both for spouses only. Of 24 patient-spouse PAIS correlations (7 subscales plus a global scale, at three times), 7 (29%) were 0.70 or greater (ps < 0.01). Of 30 FES correlations, 17 (57%) were 0.7 or higher (ps < 0.01). These results suggest that some stresses increase over time, and that spouses and patients share a similar perceived level of distress. Health professionals must address the psychological distress of the spouse as well as the patient.

A randomized trial to evaluate a computer-based learning program in occupational lung disease.

Computer based learning (CBL) is a recent educational innovation that may supplement the limited formal education typically offered to medical students in occupational health-related issues. The authors conducted a randomized trial among sophomores to evaluate a Macintosh-based application on occupational lung disease (OH-CBL). The program emphasizes interactive learning and skills practice through a case-based approach. Students taking an OH block in the Preventive Medicine course were assigned either to the OH-CBL or to the lecture group. 35 students completed the OH-CBL; 45 attended the lecture. Of four study-relevant multiple-choice questions, substantial differences were found in favor of the OH-CBL group over the lecture group on one question as well as on the study-relevant multiple choice total score. There was no difference on mean overall grade or on the three study-relevant essay items. The grade on study-relevant questions exhibited a weak relationship with microcomputer experience (r = .29, P = .04). Students' ratings of the CBL program using Likert scales were generally favorable. These findings suggest that CBL programs can be designed to be both acceptable to students and educationally effective. Each new program needs to be individually assessed to meet these standards. The authors identify several components of CBL that are necessary for successful implementation into a medical curriculum.

Pain of local anesthetics: rate of administration and buffering.

STUDY OBJECTIVE: To determine the impact of administration rate and buffering on the pain associated with subcutaneous infiltration of lidocaine. METHODS: Forty-two adult volunteers employed at a tertiary care center participated in this prospective, single-blinded study. Each subject received four lidocaine injections prepared and administered as follows: slow, buffered (SB); slow, unbuffered (SU); rapid, buffered (RB); rapid, unbuffered (RU). Buffering was accomplished by mixing 1% lidocaine with 8.4% sodium bicarbonate in a 9:1 ratio. Slow administration was 30 seconds and rapid was 5 seconds. Needle size (27-gauge), injection depth (.25 inch), lidocaine volume (1.0 mL), and temperature (room) were the same for each of the four injections. In all four conditions, the needle remained in the forearm for 30 seconds, to ensure blinding. The main outcome measure was the mean pain score for each condition, as recorded on a 10-cm visual analog scale. RESULTS: The lowest pain scores (mean +/- SE) were recorded for the SU and SB conditions at 1.49 +/- 29 and 1.48 +/- 26, respectively, and they were significantly lower than the scores for RB (2.34 +/- 28; P < .01) or RU (3.11 +/- 33; P < .001). Each of the slow conditions was reported to be the "least painful" of the four significantly more often than either rapid condition. CONCLUSION: This is the largest blinded study to assess administration rate and the pain of a local anesthetic. We found that administration rate had a greater impact on the perceived pain of lidocaine infiltration than did buffering.

Relationship of cognitions to fear of somatic symptoms: a test of the cognitive theory of panic.

The relationship between fear of physical anxiety symptoms and cognitive misinterpretation of those symptoms, as measured by responses to the Body Sensations Questionnaire and the Agoraphobic Cognitions Questionnaire, respectively, was examined for two samples of outpatients with panic disorder. Factor analytic and correlational analyses demonstrated that the patients' self-rated fear of specific physical and psychological symptoms was related to the frequency of specific logically related catastrophic thoughts (e.g., fears of heart palpitations or chest pressure with thoughts of a heart attack). This specific relationship between the somatic sensations and the catastrophic thoughts experienced by agoraphobic individuals provides further support for the cognitive theory of panic disorder. When the responses to the two questionnaires were factor-analyzed together, four factors were identified: symptoms and thoughts relevant to cardiovascular, neurological, gastrointestinal, and behavioral control systems, respectively. These findings suggest that the nature of panic-related fears varies across patients, and that the use of specific treatment interventions designed to modify the specific variations in their expression may be advisable.

Palliative pharmaceutical care: a randomized, prospective study of telephone-based prescription and medication counseling services for treating chronic pain.

OBJECTIVE: To evaluate the effects of providing a unique telephone-based pharmaceutical care program to a sample of patients enrolled at a university pain clinic in Philadelphia, Pa. We hypothesized that in comparison to routine pharmaceutical care, the telephone-based pharmaceutical care program would have a positive impact on delivery of medication, quality of life, and overall satisfaction with the pain clinic program. PATIENTS: One hundred seven pain clinic patients were randomly assigned to the control and intervention groups. Seventy-four patients (control group, n = 36; intervention group, n = 38) met inclusion criteria. METHOD: The control group continued to receive care and prescription services through the same means as prior to the study. There were 2 components to the pharmaceutical care program offered to the intervention group. The first component consisted of a palliative care pharmacy company, PainRxperts, providing specialized prescription services tailored to the needs of a pain medicine clinical practice. The second component involved the palliative-trained pharmacist's proactive monitoring of patient pharmacotherapy for potential or actual drug related problems (DRPs). RESULTS: Intervention patients perceived that they had better access to medication, more efficient processing of prescriptions, and fewer stigmatizing experiences. They also endorsed pharmacists' behavioral interventions such as medication counseling, availability to answer medication-related questions, and non-judgmental attitudes when managing opioid prescriptions. CONCLUSION: This study suggests that the palliative-trained pharmacist can play an important collaborative role in managing chronic pain. Application of the pharmaceutical care model in pain medicine centers can improve satisfaction and remove some of the barriers to good pharmaceutical care facing patients with chronic pain disorders