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Biomedical subjects

R Platt

Publications and source records attributed to R Platt.

At least 91 records · Page 5Linked to original sources
PubMed1995

Terfenadine-associated ventricular arrhythmias and QTc interval prolongation. A retrospective cohort comparison with other antihistamines among members of a health maintenance organization.

This study compared the occurrence of syncope, ventricular arrhythmias, and corrected QT interval (QTc) prolongation over a 2 1/2-year period in persons prescribed terfenadine versus other prescription antihistamines among 265,000 members of the Harvard Community Health Plan (HCHP), the largest staff-model health maintenance organization in New England. HCHP maintains an automated medical record system with coded diagnoses for each ambulatory and hospital visit, and a similar automated pharmacy system with information for each member on all prescriptions filled at its pharmacies. Among 0.86 million exposure days of terfenadine and 1.04 million exposure days of other antihistamines, we found no excess risk of either clinical/arrhythmia events (odds ratio (OR), 0.86; 95% confidence interval (CI), 0.52 to 1.44) or QTc prolongation (OR, 1.00; 95% CI, 0.64 to 1.57) during courses of terfenadine versus those of other antihistamines. Joint courses of antihistamines and oral erythromycin were associated with an increased risk of QTc prolongation (OR, 2.33; 95% CI, 1.31 to 4.15), and there was a trend for this to be observed more frequently with terfenadine (OR, 2.37; 95% CI, 0.73 to 7.51; P = 0.14).

Administration, Oral↗
PubMed1995

Serious falls in hospitalized patients: correlates and resource utilization.

PURPOSE: To evaluate the correlates of serious falls in hospitalized patients and the resource utilization associated with such falls. PATIENTS AND METHODS: This retrospective case-control study was performed in an urban tertiary care hospital. The 62 cases included all inpatients with available charts who were reported as having fallen with a resulting fracture (n = 22), dislocation (n = 1), or laceration or hematoma (n = 39) after being admitted between January 1987 and March 1991. The 62 controls were matched by date of hospitalization (within 3 months), age (within 5 years), gender, and length of stay up to the time of the fall. RESULTS: Univariate correlates of falls (P < 0.05) included severity of underlying disease, Charlson comorbidity score, and Confusion Assessment Method (CAM) score. In multivariate conditional logistic regression analyses, only the Charlson index (P < 0.006) and the CAM score (P < 0.03) were independent correlates of a fall. Exposure to any of a number of drugs did not predict falls, but the power to detect drug effects was limited. A combination of the Charlson comorbidity and CAM scores identified a population at substantially increased risk of fall, including 50% (31/62) of fallers, versus 16% (10/62) of controls (odds ratio 5.2; 95% confidence interval, 2.4 to 12). In multivariate analyses, falls were also independently correlated with increases in length of stay (P < 0.004) and total charges (P < 0.008). Fallers stayed 12 days longer and had charges $4,233 higher than controls, after adjustment for potential clinical and nonclinical confounders. CONCLUSION: Falls during hospitalization are commoner in confused patients and those with greater comorbidity. This profile differs from that of fallers in the community, probably because hospitalized patients are sicker. Injurious falls are associated with substantially increased resource utilization.

Accidental Falls↗
PubMed1995

The epidemiology of varicella and its complications.

The automated records of over 250,000 members of a health maintenance organization were analyzed to assess the epidemiology of varicella and its complications between 1 July 1990 and 30 June 1992. All complications were verified by review of full-text medical records. The incidence rates of varicella in persons < 15 years of age were 20%-50% lower than published figures, probably reflecting underreporting. The rates in those > or = 15 years old, however, were greater than those reported for 1972-1978 (607 vs. 291/10(5) years, 15-19 years old; 175 vs. 33/10(5) years, > or = 20 years old). The rates of hospitalization for uncomplicated varicella, skin superinfections, and pneumonia in children were, respectively, 15, 11, and 4 times higher than previous estimates. Hospitalization rates for adults with pneumonia and uncomplicated varicella were > 5 times higher than prior figures. Thus, varicella in adults and varicella complications in general may be more frequent than previously estimated.

Adolescent↗
PubMed1994

Ranitidine-associated autoimmune hemolytic anemia in a health maintenance organization population.

Reversible hematologic abnormalities including hemolytic anemia [1] with a positive direct Coombs' test have been associated with ranitidine. In addition to the case report cited above, the U.S. Food and Drug Administration had received five other cases of hemolysis associated with recent intake of ranitidine as of February 1991. To investigate the possible association of ranitidine with autoimmune hemolytic anemia, a study was conducted to determine how often diagnoses of hemolytic anemia or abnormal Coombs' test results followed dispensing of ranitidine using the automated medical and pharmacy records of a large health maintenance organization. No occurrences of hemolytic anemia were identified among 12,054 individuals following 38,686 prescriptions for this medication. The 95% upper confidence bound was 3.1 cases/10,000 exposed persons. One abnormal direct Coombs' test with mild anemia was discovered during routine prenatal testing of an asymptomatic patient who was dispensed ranitidine two and a half months previously. Hemolysis, however, was not demonstrated and an association with prior ranitidine use could not be confirmed. Additional analyses indicate that in only 30% of ranitidine courses was a blood count obtained. In those courses with hematocrits below 40%, less than 1% had a Coombs' test performed. Chart review suggests that the majority of individuals with severe anemia have alternative explanations other than autoimmune hemolysis for their anemia. This analysis indicates that ranitidine is unlikely to be a common cause of clinically recognized autoimmune hemolytic anemia and demonstrates the utility of large automated medical and pharmacy data bases to conduct post-marketing studies of spontaneously reported drug effects.

Ambulatory Care↗
PubMed1994

Intramuscular versus oral antibiotic therapy for the prevention of meningitis and other bacterial sequelae in young, febrile children at risk for occult bacteremia.

Because studies of the treatment of children with occult bacteremia have yielded conflicting results, we compared ceftriaxone with amoxicillin for therapy. Inclusion criteria were age 3 to 36 months, temperature > or = 39 degrees C, an acute febrile illness with no focal findings or with otitis media (6/10 centers), and culture of blood. Subjects were randomly assigned to receive either ceftriaxone, 50 mg/kg intramuscularly, or amoxicillin, 20 mg/kg/dose orally for six doses. Of 6733 patients enrolled, 195 had bacteremia and 192 were evaluable: 164 Streptococcus pneumoniae, 9 Haemophilus influenzae type b, 7 Salmonella, 2 Neisseria meningitidis, and 10 other. After treatment, three patients receiving amoxicillin had the same organism isolated from their blood (two H. influenzae type b, one Salmonella) and two from the spinal fluid (two H. influenzae type b), compared with none given ceftriaxone. Probable or definite infections occurred in three children treated with ceftriaxone and six given amoxicillin (adjusted odds ratio 0.43, 95% confidence interval 0.08 to 1.82, p = 0.31). The five children with definite bacterial infections (three meningitis, one pneumonia, one sepsis) received amoxicillin (adjusted odds ratio 0.00, 95% confidence interval 0.00 to 0.52, p = 0.02). Fever persisted less often with ceftriaxone (adjusted odds ratio 0.52, 95% confidence interval 0.28 to 0.94, p = 0.04). Although the difference in total infections was not significant, ceftriaxone eradicated bacteremia, prevented significantly more definite focal bacterial complications, and was associated with less persistent fever.

Administration, Oral↗
PubMed1994

Surveillance for surgical site infections: the uses of antibiotic exposure.

Conventional methods of surveillance for surgical site infections are resource intensive, thus creating an incentive to develop simpler alternatives. Antibiotic exposure may serve as a satisfactory marker for a physician's belief that infection is present and, therefore, may be a more efficient, and perhaps more accurate, measure than identification of an explicit diagnosis in the medical record. Surveillance strategies that use antibiotic exposure may provide resource-efficient adjuncts for surveillance of surgical site infections or be used in selected circumstances as substitutes for conventional surveillance methods.

Anti-Bacterial Agents↗
PubMed1994

Epidemiology of community-acquired Clostridium difficile-associated diarrhea.

The epidemiology of clinically recognized community-acquired Clostridium difficile-associated diarrhea was assessed in a retrospective cohort study of members of a health maintenance organization (HMO). Potential cases were identified through positive toxin assay results and confirmed by review of automated full-text medical records. Of 51 cases identified (7.7 per 100,000 person-years), 42 (82%) were diagnosed and treated exclusively in the ambulatory care setting; 33 cases occurred within 42 days after 494,491 exposures to antibiotics dispensed by an HMO pharmacy. Antibiotic-specific attack rates varied from 0 to 2040 cases per 100,000 exposures. Increased age was associated with C. difficile-associated diarrhea (P < .001). Age-adjusted antibiotic-specific attack rates were at least 10-fold higher (P < .05) for nitrofurantoin, cefuroxime, cephalexin plus dicloxacillin, ampicillin/clavulanate plus cefaclor, and ampicillin/clavulanate plus cefuroxime than for ampicillin or amoxicillin; several other antibiotics were associated with similar but not significantly increased risks.

Adolescent↗
PubMed1993

Cutaneous disease and drug reactions in HIV infection.

BACKGROUND: Skin diseases, including adverse reactions to drugs, are thought to be more common among patients with human immunodeficiency virus (HIV) infection and the acquired immunodeficiency syndrome (AIDS) than among other persons. These skin conditions can be disabling or disfiguring and may require discontinuation of essential drugs. METHODS: We identified 684 HIV-infected members of a 265,000-member health maintenance organization and reviewed their medical records to determine the frequency of dermatologic diagnoses from April 1, 1988, through January 15, 1991. We compared the rates of visits per year for skin conditions by HIV-infected men, 20 to 49 years of age, with those by non-HIV-infected men. We used an automated prescription data base to quantify exposures to drugs. RESULTS: Of the 684 HIV-infected patients, 540 (79 percent) were given one or more dermatologic diagnoses, for a total of 2281 diagnoses, including 188 cutaneous reactions to drugs. There were 43 hospitalizations for cellulitis (n = 15), cutaneous drug reactions (n = 13), or other skin problems. As compared with non-HIV-infected men, the men with AIDS had visit rates that were at least 5 times higher for 18 of the 20 most common infectious and inflammatory skin conditions and at least 15 times higher for 9 conditions. Drugs with the highest rate of cutaneous reactions (per 1000 courses) included trimethoprim-sulfamethoxazole (149), sulfadiazine (200), trimethoprim-dapsone (156), and aminopenicillins (93). The number of diagnoses of skin conditions increased according to the stage of disease: it was lowest in patients immediately before the documentation of HIV infection and highest in patients with a diagnosis of AIDS. CONCLUSIONS: Cutaneous diseases, including drug reactions, are extremely common in patients with HIV infection, and their incidence increases as immune function deteriorates.

AIDS-Related Opportunistic Infections↗
PubMed1993

Cefazolin compared with cefoxitin for cesarean section prophylaxis: the use of a two-stage study design.

The authors used a two-stage design to compare the risk of endometritis in women undergoing non-elective cesarean section who received cefazolin prophylaxis (n = 481) with those who received cefoxitin prophylaxis (n = 1799). The primary data source for this study was an automated record linkage system which allowed the ascertainment of exposure(antibiotic prophylaxis) and preliminary ascertainment of outcome (post-partum endometritis) on a consecutive sample of women undergoing cesarean section between 1 April 1987 and 30 September 1989. Potentially important covariates not available in the automated data source were sampled by review of complete medical records of a random sample of each exposure-disease category of the cohort. Of the 2280 women studied, 99 (4.3%) developed postpartum endometritis. After control for age, race, anemia, presence of ruptured membranes, parity, labor, number of vaginal examinations and payor status the adjusted odds ratio for cefazolin compared to cefoxitin was 0.95 (95% C.I. 0.5-1.9). The cost of prophylaxis was significantly higher for women who received cefoxitin prophylaxis ($56/patient vs $9.55/patient). These results suggest that cefazolin prophylaxis should be favored over cefoxitin due to lower cost and similar efficacy. This study also demonstrates the efficiency of a two-stage design in the setting where exposure and outcome are available for an entire cohort but information about important covariates is more difficult to obtain.

Adult↗
PubMed1993

Electronic surveillance of antibiotic exposure and coded discharge diagnoses as indicators of postoperative infection and other quality assurance measures.

OBJECTIVES: To assess postoperative exposure to parenteral antibiotics and coded discharge diagnoses of infection as markers of nosocomial infection, postoperative morbidity, and potentially inappropriate antibiotic use after cesarean section. DESIGN: Retrospective cohort study to compare automated markers with the criterion of record review. SETTING: Tertiary care hospital. PATIENTS: Women admitted to a large teaching hospital after April 15, 1987, and discharged before October 1, 1989, who underwent a nonrepeat, nonelective cesarean section and had received prophylaxis with a cephalosporin. METHODS: Antibiotic exposure and discharge diagnosis codes were obtained from a large electronic hospital data base. A sample of charts was reviewed to determine the presence of infection, other postoperative complications, and postoperative antibiotic exposure. RESULTS: A total of 2,197 women who had undergone a nonrepeat nonelective cesarean section were included in the study cohort. These women were assigned to 6 subgroups based on postoperative antibiotic exposure status and discharge codes suggesting endometritis, other postoperative infection, or no infection. Review of 457 records indicated that the overall infection rate was 9%. Eight percent of all the patients had a coded diagnosis for infection, and 16% received some parenteral antibiotics after the first postoperative day. Exposure to at least 2 days of parenteral postoperative antibiotics was the best marker by which to discriminate between infected and uninfected patients, with a sensitivity of 81%, a specificity of 95%, and a positive predictive value of 61% for detecting infection. The corresponding figures for coded diagnoses for infection had rates of 65%, 97%, and 74%, respectively. The combination of discharge codes and exposure to parenteral postoperative antibiotics resulted in a more accurate but less sensitive marker for nosocomial infections, with a positive predictive value of 94% and a sensitivity of 59%. The groups with discordant parenteral postoperative antibiotics exposure and discharge codes for infection were enriched for errors in coding, noninfectious morbidity, and unexplained antibiotic use. Less than 1% of the entire cohort had > or = to 2 days of parenteral postoperative antibiotics without any reason apparent in the medical record. CONCLUSIONS: Parenteral postoperative antibiotic exposure determined from automated pharmacy records correlated with the results of the more labor-intensive manual review of medical records for the identification of nosocomial infection. In addition, information on antibiotic exposure combined with coded discharge diagnoses provided a rapid screen to identify subgroups of patients with higher rates of infectious and noninfectious morbidity, unexplained antibiotic use, and errors in discharge coding. Information derived from electronic data bases created for administrative purposes may be useful as a marker for infectious complications, inappropriate antibiotic prescribing, and other issues related to total quality hospital monitoring.

Adult↗
PubMed1993

Perioperative antibiotic prophylaxis and wound infection following breast surgery.

The effectiveness of perioperative antibiotic prophylaxis against wound infections following breast surgery was investigated by meta-analysis of published data from a randomized clinical trial and an observational data set, which included a total of 2587 surgical procedures, including excisional biopsy, lumpectomy, mastectomy, reduction mammoplasty and axillary node dissection. There were 98 wound infections (3.8%). Prophylaxis was used for 44% (1141) of these procedures, cephalosporins accounted for 986 (86%) of these courses of antibiotics. Prophylaxis prevented 38% of infections, after controlling for operation type, duration of surgery and participation in the randomized trial (Mantel-Haenszel Odds Ratio = 0.62, 95% confidence interval = 0.40-0.95, P = 0.03). There was no significant variation in efficacy according to operation type or duration. We conclude that antibiotic prophylaxis significantly reduces the risk of postoperative wound infection following these commonly performed breast procedures.

Anti-Bacterial Agents↗
PubMed1993

Optimizing the assessment of disease activity during treatment with anti-rheumatoid drugs.

Clinical trials in RA usually involve the use of several laboratory assessments of disease activity. Their use is not universal and the relative value of many novel assessments has not been determined in relation to existing clinical and laboratory methods. This study attempts to investigate the value of established and novel assessments of disease activity during treatment with accepted DMARDs. Over a 48-week study period, changes in cytidine deaminase (CD), beta 2-microglobulin, alpha 1-acid glycoprotein (alpha 1-AGP), serum antibodies to Clostridium perfringens alpha-toxin, pre-albumin and caeruloplasmin were compared to a group of established clinical and laboratory assessments including plasma viscosity, CRP haemoglobin and platelet count during treatment with the established second-line drugs, D-penicillamine (n = 20), sulphasalazine (n = 17), gold (n = 12) and hydroxychloroquine (n = 18). Overall, the assessments showing the greatest degree of change were plasma viscosity, articular index, summated change score, platelet count, CD, white cell count, alpha 1-AGP, CRP and pain score. The assessments showing the greatest degree of change were not homologous between the treatment groups and no single assessment was outstanding for a particular drug treatment.

Anti-Inflammatory Agents↗
PubMed1992

Intestinal necrosis associated with postoperative orally administered sodium polystyrene sulfonate in sorbitol.

We estimated the incidence of intestinal necrosis in 752 hospitalized patients who had received sodium polystyrene sulfonate (SPS). Of these 752 patients, 117 were exposed within 1 week of surgery. Two cases of intestinal necrosis were discovered, both in patients who had received orally administered SPS in sorbitol within 1 week of surgery. Based on these two cases, the postoperative incidence of intestinal necrosis associated with SPS was 1.8%. For comparative purposes, we identified 862 patients who had undergone hemodialysis, renal transplantation, or cardiac transplantation, but did not receive SPS. No cases of idiopathic intestinal necrosis were found in this second group (P = 0.014). These data suggest that SPS in sorbitol-associated intestinal complications may be a relatively common occurrence in postoperatively exposed patients.

Administration, Oral↗
PubMed1992

Prophylaxis against wound infection following herniorrhaphy or breast surgery.

The effect of perioperative antibiotic prophylaxis on definite wound infections was assessed for 3202 herniorrhaphies or selected breast surgery procedures. Patients were identified preoperatively and monitored for greater than or equal to 4 weeks. Thirty-four percent of patients (1077/3202) received prophylaxis at the discretion of the surgeon; 86 definite wound infections (2.7%) were identified. Prophylaxis recipients were at higher risk for infection, with a higher proportion of mastectomies, longer procedures, and other factors. Patients who received prophylaxis experienced 41% fewer definite wound infections (odds ratio [OR], 0.59; 95% confidence interval [CI], 0.35-0.99; P = .04) and 65% fewer definite wound infections requiring parenteral antibiotic therapy (OR, 0.35; 95% CI, 0.15-0.88; P = .02) after adjustment for duration of surgery and type of procedure. Additional adjustment for age, body mass index, the presence of drains, diabetes, and exposure to corticosteroids did not change the magnitude of this effect meaningfully. The effect of prophylaxis was similar for all procedures studied. In the absence of formal guidelines, surgeons at these institutions administered prophylaxis preferentially to patients at highest risk.

Anti-Bacterial Agents↗
PubMed1991

Automated postdischarge surveillance for postpartum and neonatal nosocomial infections.

We developed a computerized record linkage system to determine whether it is feasible to use self-administered questionnaires to conduct large-scale, routine postdischarge surveillance for nosocomial infections among mothers and infants. We mailed questionnaires to 19,650 mothers of infants delivered at our institution who were discharged between January 1, 1988, and December 31, 1989. The questionnaire asked whether either mother or baby experienced infections, received an antibiotic, or was rehospitalized for an infection. Thirty-six percent of mothers returned the questionnaire. Seven hundred eleven (10%) of 7,033 replies reported 763 infections in mothers and 844 (12%) of 7,147 replies reported 968 infections in infants. These infections represented 4% of all women who delivered and 4% of all infants discharged. Since a minority of questionnaires were returned, these are likely to be conservative estimates of the occurrence of perceived infections. The most common maternal infections were mastitis (406 cases), urinary tract infections (185 cases), and endometritis (58 cases). The most common infections of infants were conjunctivitis (622 cases), diaper rash requiring antibiotics (169 cases), and umbilical infection (84 cases). Eighty-two percent of maternal infections reported after discharge were treated with antibiotics, as were 74% of infant infections. Infections reported during a 4-mont period were checked by a telephone call to the mother, who confirmed 17 (74%) of 23 reported maternal infections and 40 (70%) of 57 reported infant infections. Infections reported during a separate 3-month period were checked by contacting the patients' physicians, who confirmed 23 (48%) of 48 reported maternal infections and 19 (25%) of 76 reported infant infections. It is unclear how much of the low proportion of reported cases confirmed by physicians reflects overreporting by mothers and how much represents incomplete knowledge by physicians. In addition, some reported infections may have been acquired after discharge. Postdischarge surveillance via self-administered questionnaire identified twice as many apparent maternal infections and 12 times as many newborn infections as did concurrent prospective in-hospital surveillance. However, a number of important methodologic issues must be resolved.

Cross Infection↗
PubMed1991

Recurrent group A streptococcal carriage in a health care worker associated with widely separated nosocomial outbreaks.

Nine postpartum infections (five bacteremias, three cases of endometritis without bacteremia, and one infected episiotomy site) caused by an M-nontypable, T-28 strain of group A Streptococcus occurred during a 9-week period in 1987. Seven cases were cared for by one obstetrician, who was also present in the delivery suite when the remaining patients delivered. This individual was found to be an anal carrier of group A Streptococcus with the same M and T types. During the cluster, the attack rate for vaginal deliveries performed by this individual was 18% (6 of 34 patients). The individual was treated with penicillin V (500 mg four times a day for 10 days), rifampin (600 mg twice a day for 5 days), and hexachlorophene showers. Surveillance cultures of the physician were negative 1 week, 1 month, and 3 months after completion of therapy. No additional cases were identified among the next 210 vaginal deliveries performed by this individual. Fourteen months after therapy, four new cases occurred during 2 days. The physician was found to be heavily colonized once again with the original strain of group A Streptococcus and was treated with rifampin (600 mg twice a day) and oral vancomycin (250 mg four times a day) for 7 days. An open-ended regimen of penicillin V (250 mg/day) and periodic surveillance cultures was begun. During the next 19 months, this physician performed 275 vaginal deliveries, one of which resulted in an M-nontypable, T-28 group A streptococcal infection, at a time when the physician's surveillance cultures were negative. It is unclear how long a colonized health care worker who causes nosocomial group A streptococcal disease must be treated or monitored, but there is some risk after more than a year. Long-term surveillance or prophylaxis may be useful in some circumstances.

Carrier State↗