Effect of restricting contact between pharmaceutical company representatives and internal medicine residents on posttraining attitudes and behavior.

CONTEXT: The long-term effect of policies restricting contact between residents and pharmaceutical company representatives (PCRs) during internal medicine training is unknown. The McMaster University Department of Medicine in Hamilton, Ontario, implemented a policy restricting PCR contact with trainees in 1992, whereas the Department of Medicine at the University of Toronto, Toronto, Ontario, has no such policy. OBJECTIVE: To determine if the presence of a restrictive policy and the frequency of contact with PCRs during internal medicine training predict attitudes and behavior several years after completion of training. DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of the attitudes and behavior of 3 cohorts of physicians: University of Toronto trainees, prepolicy McMaster trainees, and postpolicy McMaster trainees. Surveys were mailed to 242 former University of Toronto and 57 former McMaster trainees who completed their internal medicine training between 1990 and 1996, with response rates of 163 (67%) and 42 (74%), respectively. MAIN OUTCOME MEASURES: Physician attitude, assessed by a question about the perceived helpfulness of PCR information, and behavior, assessed by whether physicians met with PCRs in the office and the frequency of contacts with PCRs (current contact score, consisting of conversations with PCRs, PCR-sponsored events attended, gifts, honoraria, and consulting fees received). RESULTS: In both the unadjusted and multiple regression analyses, postpolicy McMaster trainees were less likely to find information from PCRs beneficial in guiding their practice compared with Toronto and prepolicy McMaster trainees, with unadjusted odds ratios (ORs) of 0.44 (95% confidence interval [CI], 0.20-0.94) and 0.39 (95% CI, 0.13-1.22), respectively. All 3 groups were equally likely to report that they met with PCRs in their office in the past year (88%). Postpolicy McMaster trainees had a lower current contact score compared with Toronto (9.3 vs 10.9; P =.04) and prepolicy McMaster trainees (9.3 vs 10.8; P =.18). In multiple regression models, greater frequency of contact with PCRs during training was a predictor of increased perceived benefit of PCR information (OR, 1.29; 95% CI, 1.13-1.47) and was positively correlated with the current contact score (partial r = 0.49; P<.001). Number of PCR-sponsored rounds attended during training was not a consistent predictor of attitudes or behavior. CONCLUSIONS: Policies restricting PCR access to internal medicine trainees and the amount of contact during residency appear to affect future attitudes and behavior of physicians.

The application of decision analysis to the surgical treatment of early osteoarthritis of the wrist.

Osteoarthritis of the wrist is a complication of a number of common traumatic conditions. Arthrodesis of the radiocarpal joint, proximal row carpectomy and excision of the scaphoid, combined with midcarpal arthrodesis, have all been reported as surgical options. There have been no randomised studies comparing these procedures, and the feasibility of conducting this type of trial is limited. We used decision analysis to compare the three surgical techniques. The variables for the model used were based principally on data from the literature. Extensive sensitivity analyses were carried out to test the impact of the values given to these variables on the outcome of the model. The model indicated that the preferred treatment is proximal row carpectomy. Decision analysis allows a comparison between alternative treatments, when evidence from a randomised trial is lacking or unobtainable. The decision-analysis model may also provide insight into aspects of a problem which would be difficult, or impossible, to evaluate by a cohort study.

Randomized, controlled trial of an interactive videodisc decision aid for patients with ischemic heart disease.

OBJECTIVE: To determine the effect of the Ischemic Heart Disease Shared Decision-Making Program (IHD SDP) an interactive videodisc designed to assist patients in the decision-making process involving treatment choices for ischemic heart disease, on patient decision-making. DESIGN: Randomized, controlled trial. SETTING: The Toronto Hospital, University of Toronto, Toronto, Ontario, Canada. PARTICIPANTS: Two hundred forty ambulatory patients with MEASUREMENTS AND MAIN RESULTS: The primary outcome was patient satisfaction with the decision-making process. This was measured using the 12-item Decision-Making Process Questionnaire that was developed and validated in a randomized trial of the benign prostatic hyperplasia SDP. Secondary outcomes included patient knowledge (measured using 20 questions about knowledge deemed necessary for an informed treatment decision), treatment decision, patient-angiographer agreement on decision, and general health scores. Outcomes were measured at the time of treatment decision and/or at 6 months follow-up. Shared decision-making program scores were similar for the intervention and control group (71% and 70%, respectively; 95% confidence interval [CI] for 1% difference, -3% to 7%). The intervention group had higher knowledge scores (75% vs 62%; 95% CI for 13% difference, 8% to 18%). The intervention group chose to pursue revascularization less often (58% vs 75% for the controls; 95% CI for 17% difference, 4% to 31%). At 6 months, 52% of the intervention group and 66% of the controls had undergone revascularization (95% CI for 14% difference, 0% to 28%). General health and angina scores were not different between the groups at 6 months. Exposure to the IHD SDP resulted in more patient-angiographer disagreement about treatment decisions. CONCLUSIONS: There was no significant difference in satisfaction with decision-making process scores between the IHD SDP and usual practice groups. The IHD SDP patients were more knowledgeable, underwent less revascularization (interventional therapies), and demonstrated increased patient decision-making autonomy without apparent impact on quality of life.

Charges for medical care at different hospitals.

BACKGROUND: The United States has a high proportion of people without health insurance (15%) and a low proportion of people without employment (5%), resulting in millions who lack insurance but have some ability to pay. We tested whether hospitals charge similar prices for well-specified elective services to individuals paying out-of-pocket for medical care. METHODS: We surveyed the 2 largest general hospitals from every large city (population >500 000) in the United States and Canada. At each hospital we evaluated 5 diagnostic, 7 therapeutic, and 3 nonclinical services to determine the total charge to patients who pay directly. RESULTS: Overall, 66 hospitals were included (average, 758 beds; not-for-profit, 97% [n = 64]; teaching, 80% [n = 53]). The range in charges was substantial; for example, a screening mammogram was $40 at one hospital in Los Angeles, Calif, and $346 at one hospital in Quebec City. Charges for a screening mammogram were relatively stable between 1996 and 1997 (r=0.79; 95% confidence interval, 0.68-0.87) and unrelated to the hospital's location or charges for other services. The relative amount of variation in charges was similar for high-priced and low-priced services, similar for diagnostic and therapeutic services, and similar for the United States and Canada. CONCLUSIONS: Charges for the same hospital service vary substantially. Greater visibility might reduce some variation by bringing outliers into closer scrutiny. Patients seeking care and paying out-of-pocket could save financially by comparison shopping.

Comparing angiographic coronary revascularization strategies: a 'natural' experiment.

OBJECTIVE: To study the impact of intracoronary stents on clinical restenosis in the 'real world'. DESIGN: Retrospective comparison of the rates of clinical restenosis between two cohorts exposed to different strategies for percutaneous transcatheter intervention. The endpoint was the first of death, myocardial infarction, coronary artery bypass grafting, repeat percutaneous transluminal coronary angioplasty (PTCA) or repeat coronary angiography within nine months. SETTING: Tertiary care cardiac referral centre serving a large, metropolitan population. PATIENTS: Patients undergoing angiographic revascularization from January 1 to February 28, 1996 (the 'restricted' group [R], n=147) were compared with a before and after cohort (the 'usual' group [U], n=232, divided into those who underwent revascularization between November 1 and November 30, 1995, and those who underwent revascularization between April 1 and May 31, 1996). INTERVENTIONS: The R group was revascularized during a period of economic constraint, which imposed a shortage on stent availability. The U cohort underwent revascularization before and after the shortage (an 'unrestricted' environment for stent usage). MAIN RESULTS: There was no difference in clinical restenosis rates between the R (34.7%) and U (37.9%) groups (P=0.524, OR R/U=0.915, 95% CI 0.694 to 1.206). Also, the rate of clinical restenosis was the same among patients who underwent PTCA without stent insertion (34.8%) and those who received a stent (39.4%) (P=0.368, OR=1.13, 95% CI 0.87 to 1.44). CONCLUSIONS: At the authors' institution, a restricted stenting policy did not result in a higher clinical restenosis rate than that of usual practice.

Biotechnology stock prices before public announcements: evidence of insider trading?

BACKGROUND: Unique financial challenges faced by biotechnology companies developing therapeutics have contributed to the creation of a highly sensitive market, where stock prices are capable of great fluctuation. The potential for significant financial reward and the nature of the scientific review process make this industry susceptible to illegal share trading on nonpublic information. We examined stock prices of biotechnology products before and after announcement of Phase III clinical trial and Food and Drug Administration (FDA) Advisory Panel results for indirect evidence of insider trading. METHODS: Biotechnology stock prices were recorded for 98 products undergoing Phase III clinical trials and 49 products undergoing FDA Advisory Panel review between 1990 and 1998. Prices were recorded for 120 consecutive trading days before and after public announcement of these two events. We compared the average change in stock price of successful products ('winners') with unsuccessful products ('losers') before the public announcement of results for both critical events. RESULTS: The difference between average stock price change from 120 to 3 days before public announcement of results of Phase III clinical trial winners (+27%) and losers (-4%) was highly significant (P = 0.0007). A similar but non-significant difference was observed between the average stock price of winning (+27%) and losing products (+13%) before FDA Advisory Panel review announcements (P = 0.25). CONCLUSIONS: Our results provide indirect evidence that insider trading may be common in the biotechnology industry. Clinical investigators may wish to consider this issue before participating in any equity position in the biotechnology industry, especially if they are going to perform research for those companies.

Can the standard gamble be used to determine utilities for uncertain health states? An example using postoperative maintenance therapy in Crohn's disease.

The objective of this study was to determine whether patients with Crohn's disease (CD) value the absolute reduction in postoperative recurrence risk attributable to therapy with mesalamine (5-ASA). One hundred subjects evaluated state A (taking 5-ASA; 25% risk of recurrence), state B (not taking 5-ASA; 40% risk of recurrence), and state C (100% risk of recurrence) by rank order, visual analog scale (VAS), and standard gamble (SG). Sixty-five of 91 patients (71%) with completed and usable questionnaires had the same preference order for state A (25% risk), state B (40% risk), and state C (100% risk) on both the VAS and the SG. The mean scores for state A (25% risk), state B (40% risk), and state C (100% risk), respectively, were 67.5, 49.8, and 19.8 on the VAS and 0.977, 0.972, and 0.910 on the SG. Subgroup analyses using stepwise logistic regression showed that risk attitude seemed to be predictive of subjects' preferences for 5-ASA. These results suggest that most subjects seem to value the 15% absolute risk reduction offered by 5-ASA. Furthermore, the SG seems to be a feasible method for measuring utilities for uncertain health states in patients with CD.

Economic analysis of low-dose heparin vs the low-molecular-weight heparin enoxaparin for prevention of venous thromboembolism after colorectal surgery.

BACKGROUND: Low-dose heparin and low-molecular-weight heparin are effective strategies for preventing venous thromboembolism in colorectal surgery. The economic attractiveness of these 2 strategies in North America is unknown. We conducted an economic analysis of low-dose heparin calcium compared with enoxaparin sodium, a low-molecular-weight heparin, for thromboembolism prophylaxis after colorectal surgery. METHODS: We used decision analysis, with an economic perspective of a third-party payer. Efficacy data were obtained from the Canadian Multicentre Colorectal Deep Vein Thrombosis Prophylaxis Trial and a literature review. Canadian costs for diagnosis and treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and major bleeding were obtained from chart review and a national hospital database of colorectal surgery; American costs were obtained from published literature. The main outcomes were incremental benefits (symptomatic DVTs, symptomatic PEs, and major bleeding events avoided) and incremental costs for every 1000 patients treated. RESULTS: In the Canadian Colorectal Trial, the relative risk of DVT and PE for enoxaparin compared with low-dose heparin was 1.0 (95% confidence interval, 0.7-1.5), and the relative risk of major bleeding was 1.8 (95% confidence interval, 0.8-3.9). With the use of these data in the baseline analysis, a strategy of enoxaparin prophylaxis was associated with equal numbers of symptomatic DVTs and PEs, and an excess of 12 major bleeding episodes for every 1000 patients treated, with an additional cost of $86 050 (Canadian data) or $145 667 (US data). In a sensitivity analysis using optimal assumptions for efficacy and safety of enoxaparin (relative risk of DVT, 0.8; relative risk of PE, 0.4; relative risk of major bleeding, 1.0), a strategy of enoxaparin prophylaxis was associated with 0.8 fewer symptomatic DVT, 3 fewer symptomatic PEs, and equal numbers of major bleeding episodes for every 1000 patients treated, with an additional cost of $15 217 (Canadian data) or $107 614 (US data). CONCLUSION: Although heparin and enoxaparin are equally effective, low-dose heparin is a more economically attractive choice for thromboembolism prophylaxis after colorectal surgery.

Screening for breast cancer: time, travel, and out-of-pocket expenses.

BACKGROUND: We estimated the personal costs to women found to have a breast problem (either breast cancer or benign breast disease) in terms of time spent, miles traveled, and cash payments made for detection, diagnosis, initial treatment, and follow-up. METHODS: We analyzed data from personal interviews with 465 women from four communities in Florida. These women were randomly selected from those with a recent breast biopsy (within 6-8 months) that indicated either breast cancer (208 women) or benign breast disease (257 women). One community was the site of a multifaceted intervention to promote breast screening, and the other three communities were comparison sites for evaluation of that intervention. All P values are two-sided. RESULTS: In comparison with time spent and travel distance for women with benign breast disease (13 hours away from home and 56 miles traveled), time spent and travel distance were statistically significantly higher (P<.001) for treatment and follow-up of women with breast cancer (89 hours and 369 miles). Personal financial costs for treatment of women with breast cancer were also statistically significantly higher (breast cancer = $604; benign breast disease = $76; P < .001) but were statistically significantly lower for detection and diagnosis (breast cancer = $170; benign breast disease = $310; P < .001). Among women with breast cancer, time spent for treatment was statistically significantly lower (P = .013) when their breast cancer was detected by screening (68.9 hours) than when it was detected because of symptoms (84.2 hours). Personal cash payments for detection, diagnosis, and treatment were statistically significantly lower among women whose breast problems were detected by screening than among women whose breast problems were detected because of symptoms (screening detected = $453; symptom detected = $749; P = .045). CONCLUSION: There are substantial personal costs for women who are found to have a breast problem, whether the costs are associated with problems identified through screening or because of symptoms.

Cost comparison of predictive genetic testing versus conventional clinical screening for familial adenomatous polyposis.

BACKGROUND: Mutations of the APC gene cause familial adenomatous polyposis (FAP), a hereditary colorectal cancer predisposition syndrome. AIMS: To conduct a cost comparison analysis of predictive genetic testing versus conventional clinical screening for individuals at risk of inheriting FAP, using the perspective of a third party payer. METHODS: All direct health care costs for both screening strategies were measured according to time and motion, and the expected costs evaluated using a decision analysis model. RESULTS: The baseline analysis predicted that screening a prototype FAP family would cost $4975/ pound3109 by molecular testing and $8031/ pound5019 by clinical screening strategy, when family members were monitored with the same frequency of clinical surveillance (every two to three years). Sensitivity analyses revealed that the genetic testing approach is cost saving for key variables including the kindred size, the age of screening onset, and the cost of mutation identification in a proband. However, if the APC mutation carriers were monitored at an increased (annual) frequency, the cost of the genetic screening strategy increased to $7483/ pound4677 and was especially sensitive to variability in age of onset of screening, family size, and cost of genetic testing of at risk relatives. CONCLUSIONS: In FAP kindreds, a predictive genetic testing strategy costs less than conventional clinical screening, provided that the frequency of surveillance is identical using either strategy. An additional significant benefit is the elimination of unnecessary colonic examinations for those family members found to be non-carriers.

Direct costs of coronary artery bypass grafting in patients aged 65 years or more and those under age 65.

BACKGROUND: Over the past 20 years, there have been marked increases in rates of coronary artery bypass grafting (CABG) among older people in Canada. The objectives of this study were to accurately estimate the direct medical costs of CABG in older patients (age 65 years or more) and to compare CABG costs for this age group with those for patients less than 65 years of age. METHODS: Direct medical costs were estimated from a sample of 205 older and 202 younger patients with triple-vessel or left main coronary artery disease who underwent isolated CABG at The Toronto Hospital, a tertiary care university-affiliated hospital, between Apr. 1, 1991, and Mar. 31, 1992. Costs are expressed in 1992 Canadian dollars from a third-party payer perspective. RESULTS: The mean costs of CABG in older and younger patients respectively were $16,500 and $15,600 for elective, uncomplicated cases, $23,200 and $19,200 for nonelective, uncomplicated cases, $29,200 and $20,300 for elective, complicated cases, and $33,600 and $23,700 for nonelective, complicated cases. Age remained a significant determinant of costs after adjustment for severity of heart disease and for comorbidity. Between 59% and 91% of the cost difference between older and younger patients was accounted for by higher intensive care unit and ward costs. INTERPRETATION: CABG was more costly in older people, especially in complicated cases, even after an attempt to adjust for severity of disease and comorbidity. Future studies should attempt to identify modifiable factors that contribute to longer intensive care and ward stays for older patients.

Costs and cost-effectiveness of a universal, school-based hepatitis B vaccination program.

OBJECTIVES: This study evaluated the costs and cost-effectiveness of a school-based grade 6 universal vaccination program against hepatitis B. METHODS: We performed a descriptive cost study and cost-effectiveness analysis of British Columbia's vaccination program for 1994 and 1995. Since 1992, public health nurses have administered hepatitis B vaccine to grade 6 students in schools. We measured costs of vaccine, vaccine administration, and net program costs and used a validated Markov model to calculate the cost-effectiveness of the program. RESULTS: Vaccinating each student cost $44, $24 of which was the cost of vaccine administration. The net cost was $9 per person; considering productivity costs, net savings were $75 per person. Marginal cost per life year gained was $2100. Universal adolescent vaccination is also economically attractive in the United States but less attractive in regions with incidence rates below 3 cases per 100,000 per year. CONCLUSIONS: Hepatitis B vaccine can be delivered in North American schools at a reasonable cost. Adolescent vaccination is economically attractive in North American regions of high and average incidence rates. Our analysis supports vaccination in adolescents who remain at risk for hepatitis B virus infection.