A randomized placebo-controlled trial comparing the efficacy of etoricoxib 30 mg and ibuprofen 2400 mg for the treatment of patients with osteoarthritis.

OBJECTIVE: We compared the efficacy of etoricoxib 30 mg to placebo and ibuprofen 2400 mg for the treatment of osteoarthritis (OA) of the hip and knee. DESIGN: In this 12-week, randomized, double-blind, placebo- and active-comparator-controlled trial, 548 patients (median age 63 years) with OA of the hip or knee were randomized to receive placebo, etoricoxib 30 mg q.d., or ibuprofen 800 mg t.i.d. Demonstration of etoricoxib's efficacy vs placebo and comparison of its efficacy to ibuprofen were assessed using three co-primary endpoints: Western Ontario and McMaster's University Osteoarthritis Index (WOMAC) Pain Subscale (WOMAC-PS); WOMAC Physical Function Subscale (WOMAC-PFS); and Patient Global Assessment of Disease Status (PGADS). Each primary endpoint utilizes a 0-100 mm visual analog scale. To demonstrate comparable efficacy of etoricoxib vs ibuprofen, the 95% confidence intervals (CIs) for the difference in the least squares (LS) mean change over 12 weeks for all three co-primary endpoints had to fall within +/-10 mm. Safety and tolerability data were collected throughout the study. RESULTS: Mean baseline values for the three co-primary endpoints ranged from 62.52 to 70.14 mm. Both etoricoxib and ibuprofen demonstrated superior (P< or =0.002) efficacy for all primary endpoints. The LS mean (mm) changes (95% CI) over 12 weeks for etoricoxib and ibuprofen, respectively, compared to placebo were given as follows: WOMAC-PS: -11.66 (-16.31, -7.01) and -7.62 (-12.30, -2.94); WOMAC-PFS: -10.15 (-14.74, -5.57) and -7.23 (-11.85, -2.61); PGADS: -11.65 (-16.81, -6.50) and -8.11 (-13.30, -2.92). The efficacy of etoricoxib 30 mg was comparable to ibuprofen 2400 mg. All treatments were similarly well tolerated. CONCLUSION: Treatment with etoricoxib 30 mg q.d. provides superior efficacy vs placebo and comparable clinical efficacy vs ibuprofen 2400 mg (800 mg t.i.d.) for the treatment of OA of the hip and knee.

Intention to discontinue care among primary care patients: influence of physician behavior and process of care.

BACKGROUND: Specific elements of health care process and physician behavior have been shown to influence disenrollment decisions in HMOs, but not in outpatient settings caring for patients with diverse types of insurance coverage. OBJECTIVE: To examine whether physician behavior and process of care affect patients' intention to return to their usual health care practice. DESIGN: Cross-sectional patient survey and medical record review. SETTING: Eleven academically affiliated primary care medicine practices in the Boston area. PATIENTS: 2,782 patients with at least one visit in the preceding year. MEASUREMENT: Unwillingness to return to the usual health care practice. RESULTS: Of the 2,782 patients interviewed, 160 (5.8%) indicated they would not be willing to return. Two variables correlated significantly with unwillingness to return after adjustment for demographics, health status, health care utilization, satisfaction with physician's technical skill, site of care, and clustering of patients by provider: dissatisfaction with visit duration (odds ratio [OR], 3.2; 95% confidence interval [CI], 1.4 to 7.4) and patient reports that the physician did not listen to what the patient had to say (OR, 8.8; 95% CI, 2.5 to 30.7). In subgroup analysis, patients who were prescribed medications at their last visit but who did not receive an explanation of the purpose of the medication were more likely to be unwilling to return (OR, 4.9; 95% CI, 1.8 to 13.3). CONCLUSION: Failure of physicians to acknowledge patient concerns, provide explanations of care, and spend sufficient time with patients may contribute to patients' decisions to discontinue care at their usual site of care.

Influence of financial productivity incentives on the use of preventive care.

PURPOSE: We examined whether physician factors, particularly financial productivity incentives, affect the provision of preventive care. SUBJECTS AND METHODS: We surveyed and reviewed the charts of 4,473 patients who saw 1 of 169 internists from 11 academically affiliated primary care practices in Boston. We abstracted cancer risk factors, comorbid conditions, and the dates of the last Papanicolaou (Pap) smear, mammogram, cholesterol screening, and influenza vaccination. We obtained physician information including the method of financial compensation through a mailed physician survey. We used multivariable logistic regression to examine the association between physician factors and four outcomes based on Health Plan Employer Data and Information Set (HEDIS) measures: (1) Pap smear within the prior 3 years among women 20 to 75 years old; (2) mammogram in the prior 2 years among women 52 to 69 years old; (3) cholesterol screening within the prior 5 years among patients 40 to 64 years old; and (4) influenza vaccination among patients 65 years old and older. All analyses accounted for clus-tering by provider and site and were converted into adjusted rates. RESULTS: After adjustment for practice site, clinical, and physician factors, patients cared for by physicians with financial productivity incentives were significantly less likely than those cared for by physicians without this incentive to receive Pap smears (rate difference, 12%; 95% confidence interval [CI]: 5% to 18%) and cholesterol screening (rate difference, 4%; 95% CI: 0% to 8%). Financial incentives were not significantly associated with rates of mammography (rate difference, -3%; 95% CI: -15% to 10%) or influenza vaccination (rate difference, -13%; 95% CI: -28% to 2%). CONCLUSIONS: Our findings suggest that some financial productivity incentives may discourage the performance of certain forms of preventive care, specifically Pap smears and cholesterol screening. More studies are needed to examine the effects of financial incentives on the quality of care, and to examine whether quality improvement interventions or incentives based on quality improve the performance of preventive care.

Obstacles to collaborative quality improvement: the case of ambulatory general medical care.

OBJECTIVE: To assess the effectiveness of inter-site collaboration and report-card style feedback of quality measures on quality improvement in the outpatient setting and to identify major barriers to improvement. DESIGN: A collaborative quality improvement effort consisting of a large cross-sectional data collection effort (chart reviews and patient surveys), feedback of comparative quality of care data to improvement teams, and collaboration between sites. SETTING: Eleven primary care sites in the Boston area. STUDY PARTICIPANTS: Quality improvement teams at each site with physician leaders. INTERVENTION: Education about techniques of rapid-cycle quality improvement, coaching of on-site teams, and report-card style feedback of comparative site-specific quality of care data. RESULTS: Multiple quality improvement projects were undertaken through this collaboration. However, though we were careful to educate teams on methods of continuous quality improvement and to name specific clinical leaders, the degree of collaboration and quality improvement fell short of expectations. Major impediments to improvement included lack of team members' time and resources, lack of incentives, and unempowered team leadership. The primary obstacle to collaboration was the diversity of sites and inability of teams to create interventions that were relevant to other sites. CONCLUSION: Despite ample quality of care data, quality improvement education, and a structured collaborative process, achieving quality improvement in the ambulatory setting is still a difficult challenge. Organizations need to find ways of overcoming the obstacles faced by improvement teams in order to maximize quality improvement.

Differences in the quality of care for women with an abnormal mammogram or breast complaint.

OBJECTIVE: To examine factors associated with variation in the quality of care for women with 2 common breast problems: an abnormal mammogram or a clinical breast complaint. DESIGN: Cross-sectional patient survey and medical record review. SETTING: Ten general internal medicine practices in the Greater Boston area. PARTICIPANTS: Women who had an abnormal radiographic result from a screening mammogram or underwent mammography for a clinical breast complaint (N = 579). MEASUREMENTS AND MAIN RESULTS: Three measures of the quality of care were used: (1) whether or not a woman received an evaluation in compliance with a clinical guideline; (2) the number of days until the appropriate resolution of this episode of breast care if any; and (3) a woman's overall satisfaction with her care. Sixty-nine percent of women received care consistent with the guideline. After adjustment, women over 50 years (odds ratio [OR], 1.58; 95% [CI], 1.06 to 2.36) and those with an abnormal mammogram (compared with a clinical breast complaint: OR, 1.75; 95% CI, 1.16 to 2.64) were more likely to receive recommended care and had a shorter time to resolution of their breast problem. Women with a managed care plan were also more likely to receive care in compliance with the guideline (OR, 1.72; 95% CI, 1.12 to 2.64) and have a more timely resolution. There were no differences in satisfaction by age or type of breast problem, but women with a managed care plan were less likely to rate their care as excellent (43% vs 53%, P <.05). CONCLUSIONS: We found that a substantial proportion of women with a breast problem managed by generalists did not receive care consistent with a clinical guideline, particularly younger women with a clinical breast complaint and a normal or benign-appearing mammogram.

Drug complications in outpatients.

OBJECTIVE: Outpatient drug complications have not been well studied. We sought to assess the incidence and characteristics of outpatient drug complications, identify their clinical and nonclinical correlates, and evaluate their impact on patient satisfaction. DESIGN: Retrospective chart reviews and patient surveys. SETTING: Eleven Boston-area ambulatory clinics. PATIENTS: We randomly selected 2,248 outpatients, 20 to 75 years old. MEASUREMENTS AND MAIN RESULTS: Among 2,248 patients reporting prescription drug use, 394 (18%) reported a drug complication. In contrast, chart review revealed an adverse drug event in only 64 patients (3%). In univariate analyses, significant correlates of patient-reported drug complications were number of medical problems, number of medications, renal disease, failure to explain side effects before treatment, lower medication compliance, and primary language other than English or Spanish. In multivariate analysis, independent correlates were number of medical problems (odds ratio [OR] 1.17; 95% confidence interval [95% CI] 1.05 to 1.30), failure to explain side effects (OR 1.65; 95% CI, 1.16 to 2.35), and primary language other than English or Spanish (OR 1.40; 95% CI, 1.01 to 1.95). Patient satisfaction was lower among patients who reported drug complications (P <.0001). In addition, 48% of those reporting drug complications sought medical attention and 49% experienced worry or discomfort. On chart review, 3 (5%) of the patients with an adverse drug event required hospitalization and 8 (13%) had a documented previous reaction to the causative drug. CONCLUSIONS: Drug complications in the ambulatory setting were common, although most were not documented in the medical record. These complications increased use of the medical system and correlated with dissatisfaction with care. Our results indicate a need for better communication about potential side effects of medications, especially for patients with multiple medical problems.

Is the professional satisfaction of general internists associated with patient satisfaction?

BACKGROUND: The growth of managed care has raised a number of concerns about patient and physician satisfaction. An association between physicians' professional satisfaction and the satisfaction of their patients could suggest new types of organizational interventions to improve the satisfaction of both. OBJECTIVE: To examine the relation between the satisfaction of general internists and their patients. DESIGN: Cross-sectional surveys of patients and physicians. SETTING: Eleven academically affiliated general internal medicine practices in the greater-Boston area. PARTICIPANTS: A random sample of English-speaking and Spanish-speaking patients (n = 2,620) with at least one visit to their physician (n = 166) during the preceding year. MEASUREMENTS: Patients' overall satisfaction with their health care, and their satisfaction with their most recent physician visit. MAIN RESULTS: After adjustment, the patients of physicians who rated themselves to be very or extremely satisfied with their work had higher scores for overall satisfaction with their health care (regression coefficient 2.10; 95% confidence interval 0.73-3.48), and for satisfaction with their most recent physician visit (regression coefficient 1.23; 95% confidence interval 0.26-2.21). In addition, younger patients, those with better overall health status, and those cared for by a physician who worked part-time were significantly more likely to report better satisfaction with both measures. Minority patients and those with managed care insurance also reported lower overall satisfaction. CONCLUSIONS: The patients of physicians who have higher professional satisfaction may themselves be more satisfied with their care. Further research will need to consider factors that may mediate the relation between patient and physician satisfaction.

Differences in the professional satisfaction of general internists in academically affiliated practices in the greater-Boston area. Ambulatory Medicine Quality Improvement Project Investigators.

Managed care has created more professional constraints for general internists. We surveyed 198 general internists at 12 academically affiliated practices in the greater-Boston area to examine professional satisfaction. Overall, these physicians were moderately satisfied (mean of 59.1 on a 100-point scale). Before adjustment, women had lower overall satisfaction than men, as well as poorer satisfaction with the domains of career concerns and patient access. Gender had no independent effect on satisfaction after adjustment for age, income, percentage of time providing direct patient care, work status, and site. Younger physicians also had lower overall satisfaction, and these differences remained after adjustment. Improvements in professional satisfaction may be required to ensure the continued recruitment of young physicians, particularly women, into general internal medicine.

Preferences for cardiopulmonary resuscitation.

PURPOSE: To examine nurse-patient communication about preferences for cardiopulmonary resuscitation (CPR). DESIGN: Prospective cohort. Sampled were patients and nurses caring for patients enrolled in SUPPORT (1989-91), a multicenter study of seriously-ill hospitalized adults at four U.S. hospitals. METHODS: Information about patient preferences was obtained by interviews with patients and their designated surrogates. For selected patients, nurses were interviewed prospectively about their understanding of patients' preferences and whether they discussed these preferences with their patients. Nurse demographic information was obtained by questionnaire. Additional patient data were obtained by interview and chart review. Logistic regression was used to identify independent correlates of nurse-patient communication and nurses' understanding of patients' preferences. FINDINGS: For 1,763 study patients, 1,427 nurse interviews (response rate 81%) were obtained. The median age of interviewed nurses was 29 years; 96% were women, 68% had a bachelor's or master's degree, and 62% had worked for 5 years or more as a nurse. Nurses reported discussions about CPR with 13% of their patients, and these discussions were more likely if the nurse thought the patient did not want CPR (adjusted odds ratio [AOR] 2.68; 95% CI 1.84 to 3.90), if the nurse had spent more time with the patient (AOR 1.05; 95% CI 1.02 to 1.08) per 5 additional days, if the patient had metastatic cancer (AOR 3.56; 95% CI 1.86 to 6.78), or if the patient was in an intensive care unit at the time of study entry (AOR 2.08; 95% CI 1.26 to 3.42). Diagnosis and study site were also associated with nurses' reports of discussions with patients. Of 551 patients with available data, 58% (n = 317) wanted CPR and 30% (n = 164) did not. Nurses understood patients' CPR preferences correctly for 74% of the patients. Nurses were more likely to understand patients' preferences to forego CPR if the patient was 75 years of age or older (AOR 6.6; 95% CI 2.0 to 22.0) or if the nurse and patient had discussed the patient's preferences (AOR 25.3; 95% CI 6.5 to 98.6) or if the patient had cancer (AOR 10.9; 95% CI 2.3 to 50.1). Nurses' understanding of patients' preferences for CPR was no better than that of physicians or patients' surrogate decision-makers. CONCLUSIONS: In this sample of seriously ill hospitalized adults, discussions between patients and nurses about CPR were infrequent. Nurses' understanding of patients' preferences for care was similar to that of physicians and patients' surrogate decision-makers. Educational interventions should focus on increasing the frequency of nurse-patient discussions about end-of-life care and improving nurses' understanding of patients' preferences for care.

Efficacy and safety of cefdinir in the treatment of patients with acute bronchitis. The Cefdinir Bronchitis Study Group.

In this randomized, open-label, dose-comparative study, 18 investigators enrolled 466 patients with acute bronchitis. Patients were randomly assigned to receive either 600 mg of cefdinir once daily (QD) or 300 mg of cefdinir twice daily (BID) for 10 days. Both microbiologic and clinical efficacy were assessed at the test-of-cure visit, 7 to 14 days after therapy stopped. A total of 296 patients were classified as assessable at the test-of-cure visit (n = 150 QD, n = 146 BID). Eradication rates of baseline pathogens in these assessable patients were similar in both groups; the baseline pathogen eradication rate for assessable patients in the QD arm was 92%, and that in the BID arm was 93%. Clinical success (cure or improvement) in assessable patients was 91% and 93%, respectively. No difference was seen in the incidence of adverse events, in the incidence of diarrhea, or in the incidence of treatment withdrawals between the two groups. We conclude that cefdinir is effective and safe for the treatment of patients with acute bronchitis.

Participation of nurses in decision making for seriously ill adults.

The purpose of this study is to describe the involvement of nurses in the decision-making process of seriously ill hospitalized adults. Nurses (696) completed interviews with 1,427 patients. Patient, surrogate, and physician interviews were also completed. Patients and surrogates perceive the nurse as more influential in decision making than does the nurse or physician. Many nurses reported having no (31%) or little (36%) knowledge of their patients' preferences, and 53% of the nurses did not advocate for their patients' preferences. Only 50% of the nurses reported educating their patients about the treatment plan chosen or discussing treatment options with their patients, and few (17%) discuss prognosis. This study indicates nurses are not actively involved in the decision-making process of their patients, especially older or more experienced nurses and those working in intensive care units.

Effectiveness of five days of therapy with cefuroxime axetil suspension for treatment of acute otitis media.

BACKGROUND: In recent years there has been considerable interest in reducing the duration of antibiotic treatment regimens in patients with common bacterial infections. We conducted two independent, investigator-blinded, multicenter, randomized clinical trials, one of which included microbiologic evaluation of middle ear fluid obtained by tympanocentesis, comparing the efficacy and safety of 5 or 10 days of treatment with cefuroxime axetil suspension (CAE) with that of 10 days of treatment with amoxicillin/clavulanate suspension (AMX/CL) in children with acute otitis media. METHODS: A total of 719 pediatric patients from the ages of 3 months to 12 years were enrolled in the 2 studies. Patients received CAE for either 5 or 10 days at 30 mg/kg/day in 2 divided doses (n = 242 and 235, respectively) or AMX/CL for 10 days at 40 mg/kg/day in 3 divided doses (n = 242). Patients in the CAE (5 days) group received placebo on Days 6 through 10. In the study that included tympanocentesis, bacteriologic assessments were based on middle ear fluid cultures obtained pretreatment and, when possible, after treatment in patients with an unsatisfactory clinical outcome. RESULTS: Organisms were isolated from the pretreatment middle ear fluid specimens of 177 of 244 (73%) patients undergoing tympanocentesis, with the primary pathogens being Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis (37, 35 and 12% of isolates, respectively). Pathogens were eradicated or presumed to be eradicated in 92% (24 of 26), 84% (32 of 38) and 95% (36 of 38) of bacteriologically evaluable patients treated with CAE for 5 or 10 days or with AMX/CL, respectively. A satisfactory clinical outcome (cure or improvement) occurred in 69% (101 of 147), 70% (121 of 173) and 74% (131 of 177) of clinically evaluable patients treated with CAE (5 days), CAE (10 days) or AMX/CL, respectively. Treatment with AMX/CL was associated with a significantly higher incidence of drug-related adverse events than was treatment with CAE for either 5 or 10 days (P < 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (34% vs. 17 and 12%, respectively; P < 0.001), particularly diarrhea. CONCLUSIONS: Treatment with CAE given twice daily for 5 days is equivalent to treatment for 10 days either with the same regimen of CAE or with AMX/CL given three times daily in pediatric patients with acute otitis media.

Effectiveness of short-course therapy (5 days) with cefuroxime axetil in treatment of secondary bacterial infections of acute bronchitis.

Five hundred thirty-seven patients were enrolled in two independent, investigator-blinded, multicenter, randomized clinical trials comparing the clinical and bacteriologic efficacies and the safety of 5- or 10-day treatment with cefuroxime axetil with those of 10-day treatment with amoxicillin-clavulanate in the treatment of secondary bacterial infections of acute bronchitis. Patients received either 5 or 10 days of treatment (n = 177 in each group) with cefuroxime axetil at 250 mg twice daily or 10 days of treatment (n = 183) with amoxicillin-clavulanate at 500 mg three times daily. Patients in the cefuroxime axetil (5 days) group received placebo on days 6 to 10. Bacteriologic assessments were based on sputum specimen cultures obtained preceding and, when possible, following treatment. Organisms were isolated from the pretreatment sputum specimens of 242 of 537 (45%) patients, with the primary pathogens being Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, and Staphylococcus aureus (28, 25, 13, 9, and 8% of isolates, respectively). Pathogens were eradicated or presumed to be eradicated in 87% (52 of 60), 91% (53 of 58), and 86% (60 of 70) of bacteriologically evaluable patients treated with cefuroxime axetil (5 days), cefuroxime axetil (10 days), and amoxicillin-clavulanate, respectively. A satisfactory clinical outcome (cure or improvement) was achieved in 82% (107 of 130), 86% (117 of 136), and 83% (130 of 157) of the clinically evaluable patients treated with cefuroxime axetil (5 days), cefuroxime axetil (10 days), and amoxicillin-clavulanate, respectively. Treatment with amoxicillin-clavulanate was associated with a significantly higher incidence of drug-related adverse events than was treatment with cefuroxime axetil for either 5 or 10 days (P = 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (37 versus 19 and 15%, respectively; P < 0.001), particularly diarrhea and nausea. These results indicate that treatment with cefuroxime axetil at 250 mg twice daily for 5 days is as effective as treatment for 10 days with either the same dose of cefuroxime axetil or amoxicillin-clavulanate at 500 mg three times daily in patients with acute bronchitis. In addition, treatment with cefuroxime axetil for either 5 or 10 days is associated with significantly fewer gastrointestinal adverse events, particularly diarrhea and nausea, than is 10-day treatment with amoxicillin-clavulanate.

Clinical comparison of cefuroxime axetil and amoxicillin/clavulanate in the treatment of patients with secondary bacterial infections of acute bronchitis.

Two independent, investigator-blinded, multicenter, randomized clinical trials compared the clinical and bacteriologic efficacy and safety of two oral antibiotics, cefuroxime axetil and amoxicillin/clavulanate, in the treatment of patients with secondary bacterial infections of acute bronchitis (hereafter denoted acute bronchitis). Three hundred sixty patients with signs and symptoms of acute bronchitis were enrolled at 22 centers and were randomly assigned to receive 10 days of treatment with either cefuroxime axetil 250 mg twice daily (BID) (n= 177) or amoxicillin/clavulanate 500 mg three times daily (TID) (n = 183). Patients were assessed for both clinical and bacteriologic responses once during treatment (at 3 to 5 days) and twice after treatment (at 1 to 3 days and at 13 to 15 days). Bacteriologic assessments were based on sputum specimen cultures obtained before treatment and, when possible, after treatment. Organisms were isolated from the pretreatment sputum specimens of 162 (45%) of 360 patients, with the primary pathogens being Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae, Moraxella catarrhalis, and Staphylococcus aureus (28%, 25%, 11%, 9%, and 8% of isolates, respectively). Thirty-four percent of the H influenzae isolates and 94% of the M catarrhalis isolates that were tested for beta-lactamase production were positive. A satisfactory clinical outcome (cure or improvement) was achieved in 86% (117 of 136) and 83% (130 of 157) of the clinically assessable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (P = 0.45). With respect to the eradication of bacterial pathogens, a satisfactory outcome (cure, presumed care, or cure with colonization) was obtained in 91% (53 of 58) and 86% (60 of 70) of bacteriologically assessable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (P = 0.32). Treatment with amoxicillin/clavulanate was associated with a significantly higher incidence of drug-related adverse events than was treatment with cefuroxime axetil (39% vs 23%; P = 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (37% vs 15%; P < 0.001), particularly diarrhea and nausea. Four patients in the cefuroxime axetil group and eight patients in the amoxicillin/clavulanate group withdrew from the study because of drug-related adverse events. These results indicate that cefuroxime axetil 250 mg BID is as effective as amoxicillin/clavulanate 500 mg TID in the treatment of patients with acute bronchitis but produces fewer gastrointestinal adverse events, particularly diarrhea and nausea.

Clinical comparison of cefuroxime axetil suspension and amoxicillin/clavulanate suspension in the treatment of pediatric patients with acute otitis media with effusion.

Two independent, investigator-blinded, multicenter, randomized clinical trials, one of which included microbiologic evaluation of middle-ear fluid obtained by use of tympanocentesis, compared the efficacy and safety of two oral antibiotics, cefuroxime axetil suspension and amoxicillin/clavulanate suspension, in the treatment of children 3 months to 12 years old diagnosed with acute otitis media with effusion (AOME). Four hundred seventy-seven pediatric patients with signs and symptoms of AOME were enrolled at 20 centers and were randomly assigned to receive 10 days of treatment with either cefuroxime axetil suspension 30 mg/kg per day in two divided doses (n = 235) or amoxicillin/clavulanate suspension 40 mg/kg per day in three divided doses (n = 242). Patients were assessed for their response to treatment once during treatment (at 3 to 5 days) and twice after treatment (at 1 to 4 days and at 14 to 18 days). In the study that included tympanocentesis, bacteriologic assessments were based on middle-ear fluid cultures obtained pretreatment, and, when possible, posttreatment in patients with an unsatisfactory clinical outcome. Organisms were isolated from the pretreatment middle-ear fluid specimens of 120 (73%) of 164 patients undergoing tympanocentesis, with the primary pathogens being Streptococcus pneumoniae. Haemophilus influenzae, and Moraxella catarrhalis (27%, 24%, and 6% of isolates, respectively). Forty-four percent of the H influenzae isolates and 94% of the M catarrhalis isolates that were tested for beta-lactamase production were positive. A satisfactory clinical outcome (cure or improvement) was obtained in 70% of clinically assessable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (P = 0.40). With respect to the eradication of bacterial pathogens, in the study that included tympanocentesis a satisfactory outcome (cure or presumed cure) was obtained in 84% (32 of 38) and 95% (36 of 38) of bacteriologically assessable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (P = 0.26). Treatment with amoxicillin/clavulanate was associated with a significantly higher incidence of drug-related adverse events than was treatment with cefuroxime axetil (37% vs 16%; P < 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (34% vs 12%; P < 0.001), particularly diarrhea. Eight patients in the cefuroxime axetil group and 11 patients in the amoxicillin/clavulanate group withdrew from the studies because of drug-related adverse events. These results indicate that cefuroxime axetil suspension 15 mg/kg twice daily is as effective as amoxicillin/clavulanate suspension 13.3 mg/kg three times daily in the treatment of pediatric patients with AOME, but produces fewer gastrointestinal adverse events, particularly diarrhea.

The nurse's role in end-of-life treatment discussions: preliminary report from the SUPPORT Project.

The methods of the Study to Understand Prognosis and Preferences of Outcomes and Risks of Treatment (SUPPORT), a five year, five-center study of decision making and communication in patients near the end of life, are described. Aspects of the study propose to describe the role of the staff nurse and the specially trained nurse facilitator in decision making in patients near the end of life. The nurse is in a unique position to initiate discussions about patient preferences for end-of-life treatment and quality of life; however, a review of related research describes discordance between clinicians' understanding and patients' preferences for treatment. Ethical issues, practice barriers, and practice innovations in end-of-life treatment are discussed.

Cefpodoxime proxetil in the treatment of skin and soft tissue infections.

Patients with skin and soft tissue infections were enrolled in a study comparing 2 dosage regimens of orally administered cefpodoxime proxetil; 204 patients with mild to moderate infections received cefpodoxime proxetil 200mg twice daily and 47 patients with severe infections received 400mg twice daily. Both dosage regimens were given for 7 to 14 days. 132 of 142 (93.0%) evaluable patients in the 200mg group and 22 of 29 (75.9%) in the 400mg group were clinically cured post-therapy, the remainder in both groups being classified as improved. The pathogen eradication rate at the end of therapy in the 200mg group was 161 of 165 (97.6%), and 38 of 38 (100%) in the 400mg group. Adverse reactions (drug-related) were reported by 20 (8.0%) patients overall, and there was no apparent relationship between the dosage group and the incidence of adverse reactions. The most commonly reported reactions involved the gastrointestinal tract (diarrhoea) or female genital tract (vaginitis). Cefpodoxime proxetil appears to be a useful and safe agent in the therapy of skin and soft tissue infections.