Current and future state of FDA-CMS parallel reviews.

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) recently proposed a partial alignment of their respective review processes for new medical products. The proposed "parallel review" not only offers an opportunity for some products to reach the market with Medicare coverage more quickly but may also create new incentives for product developers to conduct studies designed to address simultaneously the information needs of regulators, payers, patients, and clinicians.

Controlled trial of interventions to increase testing and treatment for Helicobacter pylori and reduce medication use in patients with chronic acid-related symptoms.

BACKGROUND: Many symptomatic patients take proton pump inhibitors or histamine-2 blockers for years and those without gastro-oesophageal reflux disease might benefit from Helicobacter pylori eradication. AIM: To increase testing and treatment of H. pylori and reduce chronic use of proton pump inhibitors and histamine-2 blockers. METHODS: We conducted a three-armed controlled trial in 14 managed care practices. We included adults who used proton pump inhibitors or histamine-2 blockers for >1 year and excluded those with gastro-oesophageal reflux disease or previous endoscopy. We compared usual care (n = 312 patients from 6 practices) to low-intensity (n = 147 from 3 practices) and high-intensity (n = 122 from 5 practices) interventions. Low-intensity intervention consisted of guidelines, patient-lists, and a "toolkit"; high-intensity intervention added academic group detailing by a gastroenterologist with reinforcement by pharmacists. RESULTS: Compared with usual care, the high-intensity intervention increased H. pylori test-ordering (29% versus 9% at 12 months, P = 0.02). About half (23 of 58) of patients tested positive and 22 received eradication treatments. The high-intensity intervention decreased proton pump inhibitor use by 9% per year (P = 0.028), but did not alter histamine-2 blocker use. The low intensity intervention was ineffective. CONCLUSIONS: Providing guidelines, patient-lists, and toolkits was no better than usual care. Adding group detailing and pharmacist reinforcements led to improvements in H. pylori management and decreases in proton pump inhibitor use.

Lansoprazole compared with histamine2-receptor antagonists in healing gastric ulcers: a meta-analysis.

To compare the gastric ulcer healing rates of lansoprazole with histamine2-receptor antagonists (H2RAs) (ranitidine, famotidine, cimetidine, and roxatidine), a meta-analysis was performed using data from five published and eight unpublished randomized controlled trials. Analyses were performed using (1) both evaluable patients (n = 1527) and all randomized patients (n = 1655) (assuming that patients lost to follow-up were treatment failures); (2) all studies and a subset of studies that received high methodologic quality scores; and (3) fixed-effects, random-effects, and Bayesian statistical models. In all cases, lansoprazole was associated with a significantly higher rate of endoscopic healing at both 4 and 8 weeks compared with the H2RAs. When the most conservative Bayesian statistical model and intent-to-treat analysis were used, lansoprazole was associated with a 33% higher healing rate at 4 weeks (risk ratio = 1.33; 95% confidence interval [CI] = 1.19 to 1.49) and a 12% higher healing rate at 8 weeks (risk ratio = 1.12; 95% CI = 1.06 to 1.19) than were the H2RA agents. Similar results were obtained when the meta-analysis was performed on evaluable rather than all randomized patients and using the three different analytical techniques noted above. Slightly lower, though still highly significant, improvement in ulcer healing rates was obtained when the meta-analysis was performed using a subset of six studies that received high methodologic quality scores. These results support the conclusion that lansoprazole heals ulcers more quickly than do the H2RAs and also achieves higher overall rates of healing. The eradication of Helicobacter pylori associated with gastric ulcers was not assessed in individual studies.

Practice guidelines. What are internists looking for?

To determine features of the presentation of clinical practice guidelines that may enhance their use by internists, we conducted a cross-sectional survey to which 1,513 (60%) of 2,513 eligible internists responded. Endorsements by respected colleagues and by major organizations were identified as very important by 72% and 69% of respondents, respectively. Respondents preferred short pamphlets and manuals summarizing a number of guidelines and felt that concise recommendations (86%), synopsis of supporting evidence (85%), and quantification of benefit (77%) were important in guideline presentation. We conclude that guideline developers should gain the endorsement of major organizations and present key aspects in brief, easily assimilated formats.

Health care technology in the United States.

The US health care system reflects the free market of the US economy--there is no fixed budget and no limit on expenditures in the loosely structured matrix of largely private-sector health industry components. Mainly because of the inaccessibility of adequate health care for a large segment of the population, and because of the enormous cost of care threatens financial ruin for many more people, the first major reform of the system was debated in Congress for most of 1994, though, in the end, no leglislation was passed. One focus of the debate on spending has been the problem of excessive use of expensive medical technology and the need for some control, which, by and large, is lacking in the existing system. Health care technology assessment itself is a thriving industry in the United States, used by government, insurers, medical societies, hospitals, and other groups for their own purposes. At the national policy level, few opportunities for technology assessment to affect the health care industry exist, so most effort is directed at trying to affect medical practice at the level of the individual hospital and practitioner. The discernible effect of technology assessment has been minimal.

Internists' attitudes about clinical practice guidelines.

OBJECTIVE: To assess internists' familiarity with, confidence in, and attitudes about practice guidelines issued by various organizations. DESIGN: Cross-sectional, self-administered survey. PARTICIPANTS: Questionnaires were mailed to a stratified random sample of 2600 members of the American College of Physicians (ACP) in 1992. Of the 2513 internists who met our eligibility criteria, 1513 responded (60%). MEASUREMENTS AND RESULTS: Familiarity with guidelines varied from 11% of responders for the ACP guideline on exercise treadmill testing to 59% of responders for the National Cholesterol Education Program guideline. Confidence was reported in ACP guidelines by 82% of responders but by only 6% for Blue Cross and Blue Shield guidelines. Subspecialists had greatest confidence in guidelines developed by their own subspecialty organizations. It was thought that guidelines would improve the quality of health care by 70% of responders, increase health care costs by 43%, be used to discipline physicians by 68%, and make practice less satisfying by 34%. More favorable attitudes were held by internists who were paid a fixed salary, saw patients for less than 20 hours per week, had recently graduated from medical school, or were not in private practice. CONCLUSIONS: Although most ACP members studied recognized the potential benefits of practice guidelines, many were concerned about possible effects on clinical autonomy, health care costs, and satisfaction with clinical practice.

More informative abstracts of articles describing clinical practice guidelines.

UNLABELLED: Recommendations are proposed for preparing more informative abstracts of articles describing clinical practice guidelines. Information about the development and content of guidelines should be summarized with the following structure. OBJECTIVE: a succinct statement of the objective of the guideline, including the targeted health problem, the targeted patients and providers, and the main reason for developing recommendations concerning this problem for this population. OPTIONS: principal practice options that were considered in formulating the guideline. OUTCOMES: significant health and economic outcomes identified as potential consequences of the practice options. EVIDENCE: Methods used to gather, select, and synthesize evidence, and the date of the most recent evidence obtained. VALUES: persons and methods used to assign values (relative importance) to potential outcomes of alternative practice options. BENEFITS, HARMS, AND COSTS: the type and magnitude of the main benefits, harms, and costs that are expected to result from guideline implementation. RECOMMENDATIONS: a brief and specific list of key recommendations. VALIDATION: the results of any external review, comparison with guidelines developed by other groups, or clinical testing of guideline use. SPONSORS: key persons or groups that developed, funded, or endorsed the guideline. Abstracts adhering to these recommendations could enhance readers' ability to appraise the applicability, importance, and validity of guidelines for specific providers, patients, and settings. More informative abstracts could also promote the use of more explicit methods of guideline development, more consistent reporting of guideline documents, and the more appropriate use of guidelines by clinicians.

Variation in utilization of procedures for treatment of peripheral arterial disease. A look at patient characteristics.

OBJECTIVE: To examine associations between demographic characteristics and use of interventional procedures in patients with peripheral arterial disease. DESIGN: Case series drawn from a statewide hospital discharge database. SETTING: Nonfederal acute-care hospitals in Maryland. PATIENTS AND INTERVENTIONS: A total of 7080 cases of angioplasty, bypass surgery, or amputation for lower-extremity peripheral arterial disease in 1988 through 1989. MAIN OUTCOME MEASURE: Use of angioplasty, bypass surgery, and lower-extremity amputation. RESULTS: A total of 1185 angioplasties, 4005 bypass operations, and 1890 amputations were identified. Population-based annual rates showed that angioplasty use peaked at about 70 per 100,000 at the age of 65 to 74 years, bypass surgery use peaked at more than 250 per 100,000 at 75 to 84 years of age, and amputation use peaked at about 225 per 100,000 at 85 years of age and older. The age-adjusted likelihood of having a procedure for peripheral arterial disease was 1.7 times higher in men than in women and 1.6 times higher in blacks than in whites. Compared with patients who had angioplasty or bypass surgery, patients who had amputations were more likely to be more than 65 years old, to be black (odds ratio, 2.5), to have Medicaid or no insurance (odds ratio, 1.7), to have diabetes mellitus (odds ratio, 3.0), and not to have hypertension (odds ratio, 3.1). Compared with patients who had bypass surgery, patients who had angioplasty were more likely to be under 65 years old, to be white (odds ratio, 1.7), and not to have diabetes mellitus (odds ratio, 1.3). CONCLUSION: Patient race is associated with differences in the frequency with which angioplasty, bypass surgery, and amputation are performed for peripheral arterial disease, and insurance status is associated with the likelihood of having amputation.

The use of angioplasty, bypass surgery, and amputation in the management of peripheral vascular disease.

BACKGROUND: Percutaneous transluminal angioplasty has been adopted widely as a treatment for patients with peripheral vascular disease of the lower extremities. However, the effect of this procedure on the overall management of peripheral vascular disease and on the outcomes of patients has not been clearly delineated. In particular, it is not known whether angioplasty has replaced other treatments for peripheral vascular disease. METHODS: To assess the extent to which angioplasty is used and the associated changes in the surgical management of peripheral vascular disease of the lower extremities, we used data on hospital discharges in Maryland to identify all angioplasty procedures, peripheral bypass operations, and lower-extremity amputations performed for peripheral vascular disease in Maryland hospitals between 1979 and 1989. RESULTS: We estimated that from 1979 to 1989 the annual rate of percutaneous transluminal angioplasty for peripheral vascular disease of the lower extremities, adjusted for age and sex, rose from 1 to 24 per 100,000 Maryland residents (P less than 0.0001 by linear regression). Despite this increase in the use of angioplasty, the adjusted annual rate of peripheral bypass surgery also rose substantially, from 32 to 65 per 100,000 (P less than 0.001), whereas the adjusted annual rate of lower-extremity amputation remained stable at about 30 per 100,000. Total charges for hospitalizations during which a peripheral revascularization procedure was performed increased from $14.7 million in 1979 (in 1989 dollars) to $30.5 million in 1989. CONCLUSIONS: In Maryland, the adoption of percutaneous transluminal angioplasty for peripheral vascular disease of the lower extremities has been associated with an increase in the use of peripheral bypass surgery and with no decline in lower-extremity amputations. These results could be due to increased diagnosis of peripheral vascular disease, expanded indications for procedural interventions, or an increased number of repeat procedures performed in patients with peripheral vascular disease of the lower extremities.