Biomedical subjects

Roopa Seshadri

Publications and source records attributed to Roopa Seshadri.

At least 19 recordsLinked to original sources

PubMed2007

Identification of overweight status is associated with higher rates of screening for comorbidities of overweight in pediatric primary care practice.

OBJECTIVES: The goals were to determine whether primary care provider identification of children as overweight was associated with additional screening or referrals and whether the types and numbers of visits to primary care differed for overweight and nonoverweight children. METHODS: Sequential parents/guardians at 13 diverse pediatric practices completed an in-office survey addressing health habits and demographic features. Medical records of each child from a sample of families were reviewed. Data were abstracted from the first visit and from all visits in the 14-month period before study enrollment. Analyses were limited to children > or = 2 years of age for whom BMI percentile could be calculated. RESULTS: The analytic sample included 1216 children (mean age: 7.9 years; 51% male) from 777 families (parents were 43% white, 18% black, 34% Hispanic, and 5% other; 49% of families had a child receiving Medicaid/uninsured). Among overweight children (BMI of > or = 95th percentile; n = 248), 28% had been identified as such in the record. Screening or referral for evaluation of comorbidities was more likely among overweight children who were identified in the record (54%) than among overweight children who were not identified (17%). Among children at risk of overweight (BMI of 85th to 94th percentile; n = 186), 5% had been identified as such in the record and overall 15% were screened/referred. In logistic regression modeling, the children identified as overweight/at risk of overweight had 6 times greater odds of receiving any management for overweight. CONCLUSIONS: Low rates of identification of overweight status and evaluation or referrals for comorbidities were found. Identification of overweight status was associated with a greatly increased rate of screening for comorbidities.

Body Mass Index↗

PubMed2006

Oral ondansetron for gastroenteritis in a pediatric emergency department.

BACKGROUND: Vomiting limits the success of oral rehydration in children with gastroenteritis. We conducted a double-blind trial to determine whether a single oral dose of ondansetron, an antiemetic, would improve outcomes in children with gastroenteritis. METHODS: We enrolled 215 children 6 months through 10 years of age who were treated in a pediatric emergency department for gastroenteritis and dehydration. After being randomly assigned to treatment with orally disintegrating ondansetron tablets or placebo, the children received oral-rehydration therapy according to a standardized protocol. The primary outcome was the proportion who vomited while receiving oral rehydration. The secondary outcomes were the number of episodes of vomiting and the proportions who were treated with intravenous rehydration or hospitalized. RESULTS: As compared with children who received placebo, children who received ondansetron were less likely to vomit (14 percent vs. 35 percent; relative risk, 0.40; 95 percent confidence interval, 0.26 to 0.61), vomited less often (mean number of episodes per child, 0.18 vs. 0.65; P<0.001), had greater oral intake (239 ml vs. 196 ml, P=0.001), and were less likely to be treated by intravenous rehydration (14 percent vs. 31 percent; relative risk, 0.46; 95 percent confidence interval, 0.26 to 0.79). Although the mean length of stay in the emergency department was reduced by 12 percent in the ondansetron group, as compared with the placebo group (P=0.02), the rates of hospitalization (4 percent and 5 percent, respectively; P=1.00) and of return visits to the emergency department (19 percent and 22 percent, P=0.73) did not differ significantly between groups. CONCLUSIONS: In children with gastroenteritis and dehydration, a single dose of oral ondansetron reduces vomiting and facilitates oral rehydration and may thus be well suited for use in the emergency department.

Administration, Oral↗

PubMed2006

The outcome of intra-articular distal radius fractures treated with fragment-specific fixation.

PURPOSE: To assess the clinical, radiographic, and functional outcome of treating intra-articular distal radius fractures with fragment-specific fixation. METHODS: A retrospective review of 81 patients with 85 intra-articular distal radius fractures who were treated with fragment-specific fixation was performed. Minimum time to follow-up evaluation was 1 year, with a mean time of 32 months. The immediate postoperative films were compared with those taken at the final follow-up evaluation. Radiographs of the uninjured wrist were also obtained at the final follow-up evaluation for comparison. Patients were examined for wrist and finger range of motion, deformity, and grip strength, and they completed a standard Disabilities of the Arm, Shoulder, and Hand outcome survey. RESULTS: According to Gartland and Werley scoring there were 61 excellent and 24 good results. Flexion and extension of the surgically treated wrist at the final follow-up evaluation averaged 85% and 91%, respectively, of the uninjured wrist; grip strength averaged 92% compared with the uninjured side. The average Disabilities of the Arm, Shoulder, and Hand outcome score for the injured wrist was 9. Sixty-two percent of patients achieved a 100 degrees arc of flexion and extension and normal forearm rotation by postoperative week 6. Radiographic alignment was maintained between immediate postoperative and final follow-up films, and there were no cases of symptomatic arthritis at the final follow-up evaluation. CONCLUSIONS: Fragment-specific fixation is a reasonable alternative for treating intra-articular fractures of the distal radius. At final follow-up evaluations, patients had good to excellent results with respect to range of motion, grip strength, radiographic alignment, and satisfaction scores. Stable fixation allowed starting active and passive motion of the wrist without compromising postoperative alignment. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

Adolescent↗

PubMed2006

Excellent local tumor control regardless of extent of surgical resection after treatment on the Chicago Pilot II protocol for neuroblastoma.

BACKGROUND: Our aim was to investigate the impact of the extent of surgical resection on local recurrence and survival in high-risk patients treated with the Chicago Pilot II protocol. METHODS: Retrospective chart review was performed on 30 patients enrolled in the Chicago Pilot II protocol between 1995 and 2003. Variables studied were location of tumor, extent of resection, timing and location of recurrence, MYCN amplification, surgical complications, event-free survival, and overall survival (OS). Operative reports and postoperative meta-iodobenzylguanidine scans were used to assess extent of resection. Complete resection (CR) was defined as no gross residual tumor including primary and nodal disease. RESULTS: Three-year event-free survival and OS of this cohort of 30 patients was 58% and 82%, respectively. Only 1 patient developed a local recurrence, whereas metastatic recurrent disease was observed in 13 (43%) of the 30; and this subset had a significantly worse OS (23% vs 94%, P = .001). The most common relapse location was in bone. Patients with incomplete resection (IR) (11/30) and CR (19/30) had recurrence rates of 64% (7/11) and 32% (6/19, P = .12), respectively. Event-free survival was significantly better for patients with CR (68%) vs IR (27%; P = .05; odds ratio, 2.9). Overall survival rates for patients with CR vs IR were 68% vs 55%, respectively (P = .25). CONCLUSIONS: Recurrence rate was the significant determinant of survival. Patients with CR had lower recurrence rates; however, they did not have improved local control. Final outcome of patients with unfavorable neuroblastoma will be determined by metastatic recurrence, not by extent of resection.

Child↗

PubMed2006

Late second trimester assessment of pyelectasis (SERP) to predict pediatric urological outcome is improved by checking additional features.

OBJECTIVE: Counseling for pyelectasis in the late 2nd trimester is usually based only upon assessing the antero-posterior (AP) width of the renal pelvis. We hypothesized that checking additional features would better predict postnatal outcome. STUDY DESIGN: Ultrasound (<24 weeks gestational age (GA)) and newborn outcome data collected prospectively since 1986 were analyzed retrospectively. We determined if outcome predictions in kidneys with a sonographically evident renal pelvis (SERP), which had evaluation of additional features (e.g., renal and bladder lengths, presence of a dilated ureter or dilated calyces) are more accurate than those that did not have these features. RESULTS: There were 286 fetuses studied with pediatric follow-up of an average of 6.5 years. There were 338 exams providing 459 ultrasound images with SERP. Additional features were not assessed in 183 fetuses; however 103 fetuses did have evaluation of additional features. These features were categorized as abnormal (92) or as normal (11). Fetuses with SERP and abnormal additional features required extensive urological care or died 6.1 times more often than fetuses in which additional features were not examined (p < 0.001) and 12.9 times more often when additional features were normal (p < 0.001). CONCLUSION: Fetal kidneys with SERP (<24 weeks GA) and an abnormal additional ultrasound feature had extensive pediatric care significantly more often than when such features were not evaluated or were normal.

Adult↗

PubMed2005

Neonatal morbidity and growth in very low birth-weight infants after multiple courses of antenatal steroids.

OBJECTIVE: To evaluate the neonatal morbidity and the growth in very low birth-weight (VLBW) infants after exposure to multiple courses of antenatal steroids. STUDY DESIGN: A total of 319 VLBW infants were placed in one of the two groups based on exposure to antenatal steroids: Group 1: less than two complete courses; Group 2: two complete courses or more. Anthropometric measurements at birth and discharge and neonatal morbidity were recorded. Composite morbidity was defined as presence of any of the following: death, chronic lung disease, major intraventricular hemorrhage and periventricular leukomalacia. RESULTS: The composite morbidity was not significantly different between the two groups (p=0.26). A significantly higher percentage of infants born after multiple courses of antenatal steroids had head circumference below 10th percentile at discharge (23 vs 9%, adjusted OR, 3.25, (95% CI, 1.4, 7.3); p=0.015). CONCLUSIONS: Multiple courses of antenatal steroids may predispose VLBW infants to impairment of postnatal somatic growth without providing any additional benefit for immediate neonatal outcome.

Anthropometry↗

PubMed2004

Association of epigenetic inactivation of RASSF1A with poor outcome in human neuroblastoma.

PURPOSE: To investigate the prevalence and potential clinical significance of epigenetic aberrations in neuroblastoma (NB). EXPERIMENTAL DESIGN: The methylation status of 11 genes that are frequently epigenetically inactivated in adult cancers was assayed in 13 NB cell lines. The prevalence of RASSF1A and TSP-1 methylation was also analyzed in 56 NBs and 5 ganglioneuromas by methylation-specific PCR. Associations between the methylation status of RASSF1A and TSP-1 and patient age, tumor stage, tumor MYCN status, and patient survival were evaluated. RESULTS: Epigenetic changes were detected in all 13 NB cell lines, although the pattern of gene methylation varied. The putative tumor suppressor gene RASSF1A was methylated in all 13 cell lines, and TSP-1 and CASP8 were methylated in 11 of 13 cell lines. Epigenetic changes of DAPK and FAS were detected in only small numbers of cell lines, whereas none of the cell lines had methylation of p16, p21, p73, RAR-beta2, SPARC, or TIMP-3. RASSF1A was also methylated in 70% of the primary NB tumors tested, and TSP-1 methylation was detected in 55% of the tumors. RASSF1A methylation was significantly associated with age >1 year (P < 0.01), high-risk disease (P < 0.016), and poor survival (P < 0.001). In contrast, no association between TSP-1 methylation and prognostic factors or survival was observed. CONCLUSIONS: Our results suggest that epigenetic inactivation of RASSF1A may contribute to the clinically aggressive phenotype of high-risk NB.

Basic Helix-Loop-Helix Leucine Zipper Transcriptio↗

PubMed2004

Treatment of relapsed Wilms' tumor with high-dose therapy and autologous hematopoietic stem-cell rescue: the experience at Children's Memorial Hospital.

PURPOSE: To investigate whether high-dose therapy with hematopoietic stem-cell rescue (HSCR) will improve survival for patients with relapsed Wilms' tumor. PATIENTS AND METHODS: Thirteen children with relapsed Wilms' tumor were treated with one or two cycles of high-dose chemotherapy (HDT) followed by autologous HSCR. Twelve of 13 patients received reinduction chemotherapy before HDT and HSCR. The median age at diagnosis was 4.8 years, and the median time to relapse was 12 months. The histology was favorable in 12 of 13 patients. The ablative regimens included: (1) thiotepa (TT)/cyclophosphamide (CTX)/carboplatin (CP; n = 2); (2) TT/CTX (n = 5); (3) TT/etoposide (ETP; n = 1); and (4) CP/ETP/CTX (n = 1). Four patients received two cycles of HDT and HSCR. Cycle 1 consisted of CP/ETP/CTX, and melphalan/CTX were used in cycle 2. RESULTS: Seven of 13 patients are alive without evidence of disease, with a median follow-up of 30 months. The 4-year estimated event-free survival (EFS) rate is 60% (95% CI, 0.40 to 6.88), and the overall survival (OS) at 4 years is 73% (95% CI, 0.40 to 6.86). There was no transplant-related mortality. All patients engrafted to an absolute neutrophil count 500/microL at a median of 13 days (range, 8 to 62 days) and had an unsustained platelet count > 20.0 micro at a median of 16 days (range, 10 to 202 days). CONCLUSION: Our results suggest that HDT with HSCR is an effective treatment for patients with Wilms' tumor who experience relapse.

Adolescent↗

PubMed2004

Eosinophilia correlates with the presence or development of chronic graft-versus-host disease in children.

Finding predictors of chronic graft-versus-host disease (cGVHD) in children would be extremely useful. Because of recent data suggesting that cGVHD may be a Th-2-mediated process, a theoretical foundation linking eosinophilia and cGVHD exists. While an association between eosinophilia and cGVHD has been described in adults, it has never been described in children. We studied 53 patients that received allogeneic hematopoietic stem cell transplants (SCT) between 1999 and 2002. Ten (19%) of these patients developed eosinophilia (absolute eosinophil count (AEC) > 500x 10/L) after day 100. Of these ten, eight either had or later developed cGVHD. We conclude that following the peripheral eosinophil count in children post-SCT is useful, and a rise in the AEC may herald the development of cGVHD. Taking the AEC into account with other risk factors (such as previous grade II-IV acute GVHD, human leukocyte antigen (HLA)-mismatch, and unrelated donor (URD) transplant) may improve our ability to predict cGVHD.

Adolescent↗

PubMed2004

Surgical results of posterior fossa decompression for patients with Chiari I malformation.

INTRODUCTION: An increasing number of children with Chiari I malformations are coming to the attention of neurosurgeons today, although a consensus on the surgical approach to these lesions has yet to be found. METHODS: We present a retrospective analysis of posterior fossa decompression (PFD) performed at our institution on 96 patients from 1989 to 2001. Statistical analyses based on clinical and radiographic presentation and the types of surgical procedures used formed the basis for our review. RESULTS: Most of the patients with hydromyelia underwent duraplasty procedures with or without tonsillar manipulation. In contrast, most patients without hydromyelia underwent bony decompression with dural scoring and intraoperative ultrasound. PFD with bony decompression and dural scoring showed a 72% success rate, compared with 68% for duraplasty. Dural opening was not more likely to improve or arrest hydromyelia. The group subjected to duraplasty, however, had a significantly higher complication rate. Patients under the age of 8 fared better than their older counterparts. CONCLUSIONS: Overall, we favor a tailored posterior fossa craniectomy with dural scoring as the initial surgical procedure in children with Chiari I malformation with or without a syrinx. This less invasive approach minimizes complications associated with dural opening and offers comparable success rates.

Adolescent↗

PubMed2004

Neurodevelopmental outcome of very low birth weight infants after multiple courses of antenatal corticosteroids.

OBJECTIVE: To determine if two or more courses of antenatal corticosteroids are associated with neurodevelopmental impairment. METHODS: All infants born at Northwestern Memorial Hospital between 1995 and 1998, who met the following criteria, were identified: birth weight < or = 1500 g, gestational age between 24 and 34 weeks, recipient of antenatal corticosteroids, and subsequent neurodevelopmental evaluation in multidisciplinary developmental evaluation clinic. The outcomes of these infants were compared according to degree of corticosteroid exposure. This study had 80% power to detect a difference in the mental development index score of 10% or a relative risk of neurodevelopmental delay of 2.5 in the group receiving at least two courses of corticosteroids. RESULTS: Ninety-three infants were exposed to less than two full courses and 33 infants were exposed to at least two full courses of corticosteroids. The mean duration of follow-up was similar in the two groups (25 months vs 30 months, respectively, P >.05). The two groups had similar neonatal outcomes, and had no differences in any measures of neurodevelopmental outcome on follow-up. CONCLUSION: Repeated courses of antenatal corticosteroids are not associated with increased incidence of abnormalities on subsequent neurodevelopmental outcome measures.

Adrenal Cortex Hormones↗

PubMed2004

Teaching residents pediatric fiberoptic intubation of the trachea: traditional fiberscope with an eyepiece versus a video-assisted technique using a fiberscope with an integrated camera.

BACKGROUND: The authors' hypothesis was that a video-assisted technique should speed resident skill acquisition for flexible fiberoptic oral tracheal intubation (FI) of pediatric patients because the attending anesthesiologist can provide targeted instruction when sharing the view of the airway as the resident attempts intubation. METHODS: Twenty Clinical Anesthesia year 2 residents, novices in pediatric FI, were randomly assigned to either the traditional group (traditional eyepiece FI) or the video group (video-assisted FI). One of two attending anesthesiologists supervised each resident during FI of 15 healthy children, aged 1-6 yr. The time from mask removal to confirmation of endotracheal tube placement by end-tidal carbon dioxide detection was recorded. Intubation attempts were limited to 3 min; up to three attempts were allowed. The primary outcome measure, time to success or failure, was compared between groups. Failure rate and number of attempts were also compared between groups. RESULTS: Three hundred patient intubations were attempted; eight failed. On average, the residents in the video group were faster, were three times more likely to successfully intubate at any given time during an attempt, and required fewer attempts per patient compared to those in the traditional group. CONCLUSIONS: The video system seems to be superior for teaching residents fiberoptic intubation in children.

Child↗

PubMed2004

Developing an OSTE to address lapses in learners' professional behavior and an instrument to code educators' responses.

PURPOSE: To develop an instrument for measuring medical educators' responses to learners' lapses in professional behavior. METHOD: In 1999, at the Indiana University School of Medicine, a 22-item checklist of behaviors was developed to describe common responses used by educators responding to learners' lapses in professional behavior. Four medical students were trained to portray lapses in professional behaviors. These students and seven clinical observers trained to categorize behaviors as present or absent. Interrater reliability was assessed during 18 objective structured teaching evaluations (OSTEs). Videotaped OSTEs were coded twice at a one-month interval for test-retest reliability. Items were classified as low, moderate, or high inference behaviors. Script realism and educator effectiveness were assessed. RESULTS: Educators rated OSTE scripts as realistic. Raters observed an average of 6 +/- 2 educator behaviors in reaction to learners' lapses in professional behavior. Educators' responses were rated as moderately effective. More experienced educators attempted more interventions and were more effective. Agreement was high among raters (86% +/- 7%), while intraclass correlation coefficients decreased with increasing inference level. From videotaped OSTEs, raters scored each behavior identically 86% of the time. CONCLUSIONS: Accurate feedback on educators' interactions in addressing learners' professionalism is essential for faculty development. Traditionally, educators have felt that faculty's responses to learners' lapses in professional behavior were difficult to observe and categorize. These data suggest that educators' responses to learners' lapses in professional behavior can be defined and reliably coded. This work will help provide objective feedback to faculty when engaging learners about lapses in professional behavior.

Education, Medical↗

PubMed2004

Assessing symptoms and peak expiratory flow rate as predictors of asthma exacerbations.

OBJECTIVE: To investigate peak expiratory flow rate (PEFR) and quality of life scores for their ability to predict exacerbations of asthma. PARTICIPANTS AND METHODS: We identified adults who received oral or inhaled asthma medications from 36 community drugstores. We administered the McMaster Asthma Quality of Life Questionnaire (AQLQ) and measured PEFR, defining "red zone" (highest risk) as a PEFR < 50% of each patient's expected value based on gender, age, and height. We identified asthma exacerbations (breathing-related emergency department visits and hospitalizations) within 4 and 12 months after enrollment and used proportional hazards regression to assess the ability of PEFR and AQLQ scores to predict exacerbations, controlling for clinical and demographic factors. RESULTS: A red zone PEFR was a significant univariable predictor of exacerbations within 12 months (hazard ratio [HR], 1.8; 95% confidence interval [CI], 1.1 to 3.0; P =.027). However, neither a red zone PEFR, the raw PEFR, or percent of predicted maximal PEFR were significantly predictive when controlling for AQLQ scores, clinical characteristics, or demographic data (P >.2). However, the 4 subscales of the AQLQ were each significant univariable and multivariable predictors of asthma exacerbations. For example, the overall AQLQ scale had a multivariable HR of 0.63 (95% CI, 0.46 to 0.87; P =.005) for exacerbations occurring within 4 months and 0.66 (95% CI, 0.54 to 0.82; P <.001) within 12 months. CONCLUSIONS: PEFR added no predictive information to that contained in AQLQ scores and clinical and demographic data. These results support the National Institutes of Health asthma guidelines' recommendation for routinely assessing symptoms but not PEFR.

Acute Disease↗

PubMed2004

Type III secretion phenotypes of Pseudomonas aeruginosa strains change during infection of individuals with cystic fibrosis.

Pseudomonas aeruginosa is a frequent cause of respiratory exacerbations in individuals with cystic fibrosis. An important virulence determinant of this pathogen is its type III protein secretion system. In this study, the type III secretion properties of 435 P. aeruginosa respiratory isolates from 56 chronically infected individuals with cystic fibrosis were investigated. Although it had been previously reported that 75 to 90% of P. aeruginosa isolates from patients with hospital-acquired pneumonia secreted type III proteins, only 12% of isolates from cystic fibrosis patients did so, with nearly all of these isolates secreting ExoS and ExoT but not ExoU. Despite the low overall prevalence of type III protein-secreting isolates, at least one secreting isolate was cultured from one-third of cystic fibrosis patients. Interestingly, the fraction of cystic fibrosis patient isolates capable of secreting type III proteins decreased with duration of infection. Although 90% of isolates from the environment, the presumed reservoir for the majority of P. aeruginosa strains that infect patients with cystic fibrosis, secreted type III proteins, only 49% of isolates from newly infected children, 18% of isolates from chronically infected children, and 4% of isolates from chronically infected adults with cystic fibrosis secreted these proteins. Within individual patients, isolates of clonal origin differed in their secretion phenotypes, indicating that as strains persisted in cystic fibrosis patient airways, their type III protein secretion properties changed. Together, these findings indicate that following infection of cystic fibrosis patient airways, P. aeruginosa strains gradually change from a type III protein secretion-positive phenotype to a secretion-negative phenotype.

Adolescent↗

PubMed2003

Insulin pump therapy: a meta-analysis.

OBJECTIVE: To conduct a meta-analysis of the metabolic and psychosocial impact of continuous subcutaneous insulin infusion (CSII) therapy on adults, adolescents, and children. RESEARCH DESIGN AND METHODS: Studies were identified and data regarding study design, year of publication, sample size, patient's age, diabetes duration, and duration of CSII therapy were collected. Means and SDs for glycohemoglobin, blood glucose, insulin dosages, and body weight for CSII and comparison conditions were subjected to meta-analytic procedures. Data regarding pump complications and psychosocial functioning were reviewed descriptively. RESULTS: A total of 52 studies, consisting of 1,547 patients, were included in the meta-analysis. Results indicate that CSII therapy is associated with significant improvements in glycemic control (decreased glycohemoglobin and mean blood glucose). A descriptive review of potential complications of CSII use (e.g., hypoglycemia, diabetic ketoacidosis [DKA], pump malfunction, and site infections) suggests a decreased frequency of hypoglycemic episodes but an increased frequency of DKA in studies published before 1993. CONCLUSIONS: CSII therapy is associated with improved glycemic control compared with traditional insulin therapies (conventional therapy and multiple daily injections) and does not appear to be associated with significant adverse outcomes. Additional studies are needed to further examine the relative risks of CSII therapy, including the potential psychosocial impact of this technologically advanced therapy.

Age Factors↗

PubMed2002

Effectiveness of pharmacist care for patients with reactive airways disease: a randomized controlled trial.

CONTEXT: It is not known whether patient outcomes are enhanced by effective pharmacist-patient interactions. OBJECTIVE: To assess the effectiveness of a pharmaceutical care program for patients with asthma or chronic obstructive pulmonary disease (COPD). DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial conducted at 36 community drugstores in Indianapolis, Ind. We enrolled 1113 participants with active COPD or asthma from July 1998 to December 1999. Outcomes were assessed in 947 (85.1%) participants at 6 months and 898 (80.7%) at 12 months. INTERVENTIONS: The pharmaceutical care program (n = 447) provided pharmacists with recent patient-specific clinical data (peak expiratory flow rates [PEFRs], emergency department [ED] visits, hospitalizations, and medication compliance), training, customized patient educational materials, and resources to facilitate program implementation. The PEFR monitoring control group (n = 363) received a peak flow meter, instructions about its use, and monthly calls to elicit PEFRs. However, PEFR data were not provided to the pharmacist. Patients in the usual care group (n = 303) received neither peak flow meters nor instructions in their use; during monthly telephone interviews, PEFR rates were not elicited. Pharmacists in both control groups had a training session but received no components of the pharmaceutical care intervention. MAIN OUTCOME MEASURES: Peak expiratory flow rates, breathing-related ED or hospital visits, health-related quality of life (HRQOL), medication compliance, and patient satisfaction. RESULTS: At 12 months, patients receiving pharmaceutical care had significantly higher peak flow rates than the usual care group (P =.02) but not than PEFR monitoring controls (P =.28). There were no significant between-group differences in medication compliance or HRQOL. Asthma patients receiving pharmaceutical care had significantly more breathing-related ED or hospital visits than the usual care group (odds ratio, 2.16; 95% confidence interval, 1.76-2.63; P<.001). Patients receiving pharmaceutical care were more satisfied with their pharmacist than the usual care group (P =.03) and the PEFR monitoring group (P =.001) and were more satisfied with their health care than the usual care group at 6 months only (P =.01). Despite ample opportunities to implement the program, pharmacists accessed patient-specific data only about half of the time and documented actions about half of the time that records were accessed. CONCLUSIONS: This pharmaceutical care program increased patients' PEFRs compared with usual care but provided little benefit compared with peak flow monitoring alone. Pharmaceutical care increased patient satisfaction but also increased the amount of breathing-related medical care sought.

Adult↗

PubMed2002

A phase I study of weekly gemcitabine and docetaxel in patients with advanced cancer: a Hoosier Oncology Group Study.

PURPOSE: To determine the maximum tolerated dose (MTD) of weekly gemcitabine plus docetaxel, a dose escalation trial of both drugs was developed with each administered weekly for 3 weeks out of 4. PATIENTS AND METHODS: Dose levels for gemcitabine (mg/m(2)) and docetaxel (mg/m(2)) were as follows: level 1: 600/25; level 2: 600/35; level 3: 750/35; and level 4: 900/35. Sixteen patients with adequate renal, hepatic, and hematologic function and an Eastern Cooperative Oncology Group performance status of 0-2 were treated. Primary sites included pancreas (12) and others (4). RESULTS: Three patients were treated at each dose level from level 1 through level 4. The dose-limiting toxicity (DLT) was neutropenia, the maximum tolerated dose being 750 mg/m(2) of gemcitabine and 35 mg/m(2) of docetaxel. No grade 4 nonhematologic toxicity was seen. Three patients had grade 4 neutropenia. Of the 12 patients with pancreatic cancer, 1 had a partial remission and 7 had stable disease with a median duration of 8 weeks. CONCLUSIONS: Gemcitabine and docetaxel can be safely administered weekly at a dose of 750 and 35 mg/m(2), respectively. The DLT was neutropenia. Disease stabilization suggests that this may be an active regimen in patients with metastatic pancreatic cancer.

Adult↗