Clinical judgment and clinical practice guidelines.

Clinicians make judgments under conditions of uncertainty. Decision research has shown that in uncertain situations individuals do not always act rationally, coherently, or to maximize their expected utility. Advocates of clinical guidelines believe that these guidelines will eliminate some of the cognitive biases that the practitioner may introduce into the medical decision-making process in an attempt to reduce its uncertainty. Other physicians have grave doubts about guidelines' application in practice. Guideline implementation lags well behind their development. Studies of practicing physicians and a survey of clinicians in one specialty and setting indicate that experienced clinicians may be implementing guidelines selectively. Many clinicians are concerned that guidelines are based on randomized trials and do not reflect the complexity of the real world, in which a decision's context and framework are important. Their reluctance also may be due to the difficulty of applying general guidelines to specific clinical situations. The problem will only increase in the future. The patients of the 21st century will be older and have more complex disease states. Physicians will have more patient-specific therapies and need to exercise more sophisticated clinical judgment. They may be more willing to use guidelines in making those judgments if research can demonstrate guidelines' effectiveness in improving decision making for individual patients.

Compliance and hypertension.

Despite decades of attention to noncompliance to treatment for hypertension, the problem remains a significant factor in the inadequate control of blood pressure. Current approaches to enhancing compliance use patient demographics, medication characteristics, clinical factors, health beliefs, and the quality of patient-provider communication. Clinical researchers are just beginning to apply a new approach that views compliance as a behavior change taking place over time. In this view, patients do not simply change their behavior through a one-time decision to take their medication as directed by their physicians; they move through five stages of behavior change. Clinicians can increase compliance by assessing their patients to determine the patient's stage of behavior change, then matching their interventions to that stage.

Postmarketing studies: benefits and risks.

OBJECTIVE: To consider the benefits and risks of large postmarketing outcomes studies, as demonstrated by studies of the statin drugs. METHODS: Literature review. RESULTS: The risks were that the statin studies had a strong coat-tail effect. Each new study was beneficial to all statins as well as the one studied. Economic analyses based on the results of the postmarketing studies concluded that the drugs were not cost-effective. Long-term postmarketing studies were slow to be put into perspective and did not immediately influence other researchers or clinicians. During that time, the sponsoring companies shouldered opportunity costs as well as the actual costs of the studies. The risk that one drug company would use another company's results instead of investing in their own research did not materialize. The benefits were that the studies definitively showed that the drugs and the lowering of lipids were safe and efficacious. The studies also expanded the indications for the drugs, generated goodwill in the medical and research communities for the sponsors, allowed sponsors to include specific claims in their advertisements, generated follow-up studies, spawned economic analyses that sparked interest in the medical and lay press, and had a major impact on clinicians' use of the drug. CONCLUSION: The risks and benefits of postmarketing studies may depend on the company's time perspective. In the short term, the risks may outweigh the benefits. Only companies that have a longer perspective may find it beneficial to undertake large postmarketing studies.

Changes in HIV risk behavior following alternative residential programs of drug abuse treatment and AIDS education.

We compared the effectiveness in changing human immunodeficiency virus (HIV) risk behavior of two different approaches to acquired immunodeficiency syndrome (AIDS) education given by residential drug abuse treatment programs differing in their planned duration. Two randomized controlled trials compared (a) a 6-month with a 12-month therapeutic community (TC) program, and (b) a 6-month with a 3-month relapse prevention (RP) program. Three composite variables assessing HIV risk (a) drug injection, (b) sexual partners, and (c) condom use-were measured for the 3 months prior to admission and follow-up. The TC program comprised a four-part AIDS information intervention. The RP program comprised a 21- or 42-session small-group program in the principles of RP, 5 skills-building AIDS education sessions, and 6 other health education sessions. Four hundred ninety-five clients were enrolled in the study and completed a follow-up interview within 6 months of exit (79% of those enrolled). Clients in the RP program reduced their drug injection and condom use risk. Female clients in the TC program reduced their condom use risk. There were no differential effects on risk behavior change of either planned duration (randomization assignment) or program type (RP versus TC). Thus, differences in the treatment programs, including AIDS education components, had no apparent effect on HIV risk behavior change. The contribution of residential drug abuse treatment programs to AIDS prevention remains unproved.

A comparison of clinical and psychological effects of fentanyl and nalbuphine in ambulatory gynecologic patients.

Drug dosages, length of stay (LOS), and incidence of psychological side effects of fentanyl and nalbuphine were compared in a randomized, double-blind study using unpremedicated female day-surgery patients undergoing diagnostic laparoscopy. Patients received either fentanyl 1.5 micrograms/kg (F group; n = 142), low-dose nalbuphine 300 micrograms/kg (LN group; N = 103), or high-dose nalbuphine 500 micrograms/kg (HN group; n = 41), intravenously (IV) before anesthesia consisting of thiopental, N2O, O2, and a succinylcholine infusion. Additional IV intraoperative and IM postoperative opioids were given if required for signs of inadequate anesthesia or postoperative pain. The patients' clinical and psychological status was evaluated at 20-min intervals postoperatively by a team of trained interviewers. The low- and high-dose nalbuphine groups clinically resembled the fentanyl group in terms of dosing frequency and patients' self-ratings of postoperative analgesia. Length of stay and postoperative sedation were significantly greater with nalbuphine. The incidence of psychological side effects, including dreaming and postoperative anxiety, was also greater with nalbuphine. However, patient acceptance of nalbuphine was high and was similar to that observed in patients given fentanyl.

Effects of nitrous oxide on decision-strategy and sustained attention.

Effects of 10,20, and 30% N2O on decision-making strategy, reaction-times, sustained attention, the Digit Symbol Subsititution Test (DSST), short-term memory and the Clyde Mood Scale were assessed in 12 test subjects. Decision-making strategy, as measured by 2-choice probability-learning, was unaffected by 30% N2O once a strategy had been formulated, but reaction-times were increased. Sustained attention was significantly affected in 33% of our subjects, whereas performance on the DSST and on the short-term memory task was impaired in virtually all subjects. Changes were noted in several mood-scale factors with 30% N2O. No residual drug effects were found.