[Show abstract][Hide abstract] ABSTRACT: The object of the study was to evaluate outcomes of a randomized clinical trial (RCT) of a pharmacist intervention for depressed patients in primary care (PC). We report antidepressant (AD) use and depression severity outcomes at 6-months. The RCT was conducted between 1998 and 2000 in 9 eastern Massachusetts PC practices. We studied 533 patients with major depression and/or dysthymia as determined by a screening test done at the time of a routine PC office visit. The majority of participants had recurrent depressive episodes (63.5% with >/=4 lifetime episodes), and 49.5% were taking AD medications at enrollment. Consultation in person and by telephone was performed by a clinical pharmacist who assisted the primary care practitioner (PCP) and patient in medication choice, dose, and regimen, in accordance with AHCPR depression guidelines. Six-month AD use rates for intervention patients exceeded controls (57.5% vs. 46.2%, P =.03). Furthermore, the intervention was effective in improving AD use rates for patients not on ADs at enrollment (32.3% vs. 10.9%, P =.001). The pharmacist intervention proved equally effective in subgroups traditionally considered difficult to treat: those with chronic depression and dysthymia. Patients taking ADs had better modified Beck Depression Inventory (mBDI) outcomes than patients not taking ADs, (-6.3 points change, vs. -2.8, P =.01) but the outcome differences between intervention and control patients were not statistically significant (17.7 BDI points vs. 19.4 BDI points, P =.16). Pharmacists significantly improved rates of AD use in PC patients, especially for those not on ADs at enrollment, but outcome differences were too small to be statistically significant. Difficult-to-treat subgroups may benefit from pharmacists' care.
Full-text · Article · May 2004 · General Hospital Psychiatry
[Show abstract][Hide abstract] ABSTRACT: The objective of this article is to provide a detailed description of interactions between patients with depression and pharmacists. Analysis was conducted on patients from the intervention arm (n=268) of an randomized controlled trial that evaluated the impact of a clinical pharmacist on the outcomes for depressed primary care patients from nine metropolitan Boston practices. The main outcome measure was the amount of intervention time spent with patients, physicians, and other activities. Details of the behavioral intervention and a categorization of the activities are offered. Pharmacists reported 978 encounters with 268 patients in 6 months. Eighty percent of patient encounters occurred by telephone. Initial encounters took 45 min if in person and 13.3 min if by telephone. Subsequent encounters followed a similar pattern. Follow-up visits occurred 2.3 times per patient. Physician contact took considerably less time. In total, the pharmacist intervention took 70.3 min per patient over 6 months; 42.2% of encounters involved an activity related to non-antidepressant medication and 85% of encounters involved general support. Other activities (education, advocating antidepressants, and motivating adherence) occurred in at least 50% of encounters. Pharmacists repeated intervention activities in the same category approximately two to three times. Interventions to improve the care of depression in primary care patients must anticipate encountering intense needs for information, personal support, and help negotiating the healthcare system. Research that identifies relationships between the components (active ingredients) of an intervention and the outcomes of care will benefit future intervention strategies and contribute to improved and efficient care.
No preview · Article · May 2004 · General Hospital Psychiatry
[Show abstract][Hide abstract] ABSTRACT: Skin cancer is a well-recognized long-term complication of transplantation and immunosuppression. Although risk factors for the development of skin cancer in the general population are well defined, risk factors for the development of these lesions have not been identified clearly in the liver transplant population. We surveyed 151 liver transplant (LTx) recipients for risk factors associated with cutaneous malignancies in the general population. Variables included were: demographics, primary liver disease, severity of disease at LTx, immunosuppression history, complexion, hair color, eye color, tanning profile, number of moles, occupational history, sun exposure history, sunburn history, family history of skin cancer, and any history of removed skin lesions. All skin cancers were confirmed histologically. There were 86 documented skin cancers in 34 patients: 56 squamous cell, 23 basal cell and 7 melanomas. Median follow-up was 1490 days. In a univariate analysis, age, male gender, red hair, brown eyes, primary sclerosing cholangitis (PSC), primary biliary cirrhosis (protective), cyclosporine, number of second degree sunburns, and frequent lifetime sun exposure were associated with the development of new skin cancers. In a multivariate model, age, male gender, red hair, brown eyes, PSC, and cyclosporine remain the strongest predictors. The incidence of skin cancer after liver transplantation is underestimated. In particular, there is a higher incidence of squamous cell carcinoma compared with the general population. Recipients with identified risk factors may be candidates for prophylactic treatment and should be followed more intensively after liver transplantation.
Preview · Article · Nov 2002 · Liver Transplantation
[Show abstract][Hide abstract] ABSTRACT: To determine the effect on margin evaluation for patients with breast cancer, we prospectively quantified the "flattening" of the breast specimen after surgical removal.
The volume and height of 100 consecutive breast biopsy specimens were recorded independently by the operating surgeon and the pathologist. Five factors were analyzed that were thought to contribute to changes in specimen dimensions: patient age, breast tissue density, mammographic lesion type, specimen size, and the use of compression during specimen radiography.
After surgical removal, mean volume and height of the breast specimens decreased from 46 cm(3) to 29 cm(3) (30%) and from 2.6 cm to 1.4 cm (46%), respectively. Flattening of the breast specimens occurred in all subgroups studied.
Breast specimens are flattened after surgical removal, losing almost 50% of their original height. This "pancake" phenomenon has important implications for the accuracy of margin analysis.
No preview · Article · Sep 2002 · The American Journal of Surgery
[Show abstract][Hide abstract] ABSTRACT: To determine the sensitivity, specificity, and predictive values of cultures done with blood drawn through a central venous or arterial catheter compared with peripheral venipuncture.
Retrospective cohort study of critically ill surgical patients in whom samples for paired cultures were drawn through a central venous or arterial catheter and peripheral venipuncture.
Tertiary-care, university-affiliated medical center.
Two hundred seventy-one patients hospitalized on a surgical and a cardiothoracic intensive care unit between November 1994 and August 1997.
Blinded assessments of culture results done by two physicians were used as the gold standard. Sensitivity, specificity, and positive and negative predictive values were compared for culture of blood from catheters and culture of blood from peripheral venipuncture. Of 499 observations, 426 were catheter-negative/venipuncture-negative, 19 were catheter-positive/venipuncture-positive, 18 were catheter-negative/venipuncture-positive, and 36 were catheter-positive/venipuncture-negative pairs. For catheter draws compared with peripheral venipuncture, sensitivity was 78% (confidence interval [CI], 65% to 90%) and 65% (CI, 50% to 79%) (p = .2), specificity was 95% (CI, 94% to 97%) and 98% (CI, 97% to 99%) (p = .002), positive predictive value was 63% (CI, 51% to 76%) and 78% (CI, 64% to 91%) (p = .1) and negative predictive value was 98% (CI, 96% to 99%) and 97% (CI, 95% to 98%) (p = .3). When central venous specimens as differentiated from arterial catheter specimens were compared with peripheral venipuncture, the difference between positive predictive values reached statistical significance (61% and 82%; p = .04).
In critically ill surgical patients, cultures of blood drawn through a catheter are less specific than those obtained from a peripheral venipuncture. Both types of cultures have an excellent negative predictive value. Positive predictive value of cultures of blood drawn through a catheter is low and, when obtained from a central line, statistically less than from a peripheral venipuncture. Additional cultures seem to be necessary for the proper interpretation of a positive culture drawn through a catheter in critical care patients.
Full-text · Article · Feb 2002 · Critical Care Medicine
[Show abstract][Hide abstract] ABSTRACT: Individual physicians who are paid prospectively, as in capitated health plans, might tend to encourage patients to avoid or to join these plans according to the patient's health status. Though insurance risk selection has been well documented among organizations paid on a prospective basis, such physician-level risk selection has not been studied.
To assess physician reports of risk selection in capitated health plans and explore potentially related factors.
National mailed survey of primary care physicians in 1997-1998, oversampling physicians in areas with more capitated health plans.
The response rate was 63% (787 of 1,252 eligible recipients). Overall, 44% of physicians reported encouraging patients either to join or to avoid capitated health plans according to the patients' health status: 40% encouraged more complex and ill patients to avoid capitated plans and 23% encouraged healthier patients to join capitated plans. In multivariable models, physicians with negative perceptions of capitated plan quality, with more negative experiences in capitated plans, and those who knew at each patient encounter how they were being compensated had higher odds of encouraging sicker patients to avoid capitated plans (odds ratios, 2.0, 2.2, and 2.0; all confidence intervals >1).
Many primary care physicians report encouraging patients to join or avoid capitated plans according to the patient's health status. Although these physicians' recommendations might be associated primarily with concerns about quality, they can have the effect of insulating certain health plans from covering sicker and more expensive patients.
Full-text · Article · Jan 2002 · Journal of General Internal Medicine
[Show abstract][Hide abstract] ABSTRACT: To explore the possible interaction between human herpesvirus 6 (HHV-6) and cytomegalovirus (CMV) in patients who have undergone
organ transplantation, stored serum samples from 139 orthotopic liver transplant recipients were tested for HHV-6 immunoglobulin
(Ig) G and IgM antibodies. HHV-6 reactivation occurred in 87 patients (62.6%) and was associated with CMV disease (P = .01), severe CMV-associated disease (P = .01), older age (P = .005), and use of muromonab-CD3 (Orthoclone; Orthobiotech) as treatment for rejection (P = .02). Trends for an association between HHV-6 reactivation and invasive fungal disease (P = .12), bacteremia (P = .10), and graft loss (P = .12) were seen. In a multivariate analysis of risk factors for severe CMV-associated disease, HHV-6 reactivation (relative
risk [RR], 3.5; 95% confidence interval [CI], 1.2–10.2; P = .02), CMV donor-positive-recipient-negative match (RR, 5.7; 95% CI, 2.5–13.2; P < .001), and elevated serum creatinine level (P < .0001) were independent predictors. HHV-6 reactivation is associated with severe CMV-associated disease in liver transplant
Preview · Article · Oct 2001 · Clinical Infectious Diseases
[Show abstract][Hide abstract] ABSTRACT: Depot-medroxyprogesterone acetate (DMPA) is thought to cause changes in mood among patients using it for contraception. The purpose of this study was to evaluate changes in negative and positive affect among adolescent females using DMPA as a contraceptive agent.
This prospective study was set in an urban hospital adolescent clinic. Thirty-nine adolescents choosing DMPA as a contraceptive agent and 24 adolescents not using any hormonal contraception were enrolled as subjects and controls, respectively. Two standardized questionnaires, the Beck Depression Inventory (BDI) and the Multiple Affect Adjective Checklist-Revised (MAACL-R), were administered at baseline to all participants and readministered at 3, 6, and 12 months.
Changes in negative affect from baseline to 3, 6, and 12 months were evaluated by the BDI and by "dysphoria" subscale scores of the MAACL-R. Paired t-tests were used to measure these changes in subjects and controls separately.
The mean change in BDI scores from baseline to one year for those who completed one year was -4.8 for subjects (P =.02) and +.3 (P =.84) for controls. The mean change in the dysphoria subscale scores was -5.7 (P =.21) for the subjects and -.1 (P =.98) for the controls while the change in the positive affect scores over a period of one year were -2.1 (P =.46) and +.1 (P =.98) for subjects and controls, respectively.
Adolescents using DMPA do not show depressive symptoms when using DMPA as a contraceptive agent over a period of 12 months as measured by the BDI and show no significant changes in negative or positive affect as measured by the MAACL-R.
No preview · Article · Jun 2001 · Journal of Pediatric and Adolescent Gynecology
[Show abstract][Hide abstract] ABSTRACT: The current study was conducted to review the authors' experience in treating consecutive patients with American Joint Committee on Cancer (1997 revision) Stage III nonsmall cell lung carcinoma with aggressive preoperative chemoradiation followed by surgical resection.
The records of all patients who received preoperative chemoradiation were evaluated. Patients received 2 cycles of concurrent cisplatin and etoposide with 5940 centigrays of radiation therapy. They then were reevaluated to determine whether they were surgical candidates. If so, resection of the primary tumor with mediastinal lymph node dissection was performed 4-6 weeks after the completion of preoperative treatment. After adequate healing, an additional four cycles of cisplatin/etoposide or carboplatin/paclitaxel was given.
Forty-two patients received preoperative chemoradiation, 33 of whom underwent surgical resection (79%), including 9 patients who underwent pneumonectomies. Complete pathologic responses were observed in 27% of these patients. Postoperative complications were noted in 21% of the patients and included persistent air leak, supraventricular arrhythmia, and empyema. There were no reported treatment-related deaths. The median follow-up was 26 months. The overall 5-year survival rate for all patients was 36.5% and was 45. 3% for patients who underwent resection. A trend toward increased 5-year survival was observed in patients who had a complete pathologic response (57.1%). Univariate analysis revealed the N stage classification to be significant for predicting a complete response. Patterns of failure revealed the brain to be the most common site of first recurrence (50%) and the only site of recurrence in 36% of patients. There was only one case of local failure.
Preoperative chemoradiation using high radiation doses is feasible with acceptable toxicity. The results of the current study suggest an increased complete pathologic response rate and increased overall survival rate compared with reports in the published literature.
[Show abstract][Hide abstract] ABSTRACT: Conduction abnormalities and arrhythmias may occur in patients following secundum atrial septal defect (ASD) closure using the Amplatzer® septal occluder (ASO). Therefore, the aim of this study was to prospectively perform ambulatory ECG monitoring to assess the electrocardiographic effects of transcatheter closure (TCC) of ASD using the ASO device.
From 5/97 to 3/99, 41 patients with secundum ASD, underwent TCC using the ASO device at a median age of 9.2[emsp4 ]y. (0.5–87[emsp4 ]y.) and median weight of 34[emsp4 ]kg (5.6–88[emsp4 ]kg.). Ambulatory Holter monitoring was performed pre- and immediately post TCC. Holter analysis included heart rate (HR), ECG intervals, supraventricular ectopy (SVE), ventricular ectopy (VE), and AV block.
No change in baseline rhythm was noted in 37 patients (90%). Changes in AV conduction occurred in 3 patients (7%), including intermittent second degree AV block type II, and complete AV dissociation post closure. SVE was noted in 26 patients (63%) post closure, ranging from 5–2207 supraventricular premature beats (SVPB), including 9 patients (23%) with non-sustained supraventricular tachycardia (SVT), 3 of whom had short runs of SVT prior to closure. A significant increase in post-closure number of SVPB per hour (p=0.047) was noted. No significant difference was noted in PR interval, ventricular premature beats per hour, or QRS duration.
Conclusions: Based on ambulatory ECG analysis, TCC of ASD with the ASO device is associated with an acute increase in SVE and a small risk of AV conduction abnormalities, including complete heart block. Long term follow-up studies will be necessary to determine late arrhythmia prevalence and relative frequency compared with standard surgical ASD repair.
No preview · Article · Nov 2000 · Journal of Interventional Cardiac Electrophysiology
[Show abstract][Hide abstract] ABSTRACT: The in vitro antibacterial activities of clinafloxacin, trovafloxacin, ciprofloxacin, and cefoxitin against 1,000 clinical
isolates of Bacteroides fragilis group were compared by agar dilution in brucella blood agar (BBA) and Wilkins Chalgren agar (WCA). Significantly higher geometric
mean MICs for the three quinolones and cefoxitin (P < 0.001) were obtained in BBA than in WCA. Regardless of medium, clinafloxacin was slightly more active than trovafloxacin.
The activity of clinafloxacin and trovafloxacin was greater than that of cefoxitin against B. distasonis, B. ovatus, and B. thetaiotaomicron but lower against B. vulgatus. High cross resistance between trovafloxacin and clinafloxacin was observed.
[Show abstract][Hide abstract] ABSTRACT: Nonimmunosuppressed individuals possessing a NcoI restriction enzyme site in the tumor necrosis factor (TNF) gene locus produce less TNF-alpha in vitro and in vivo than do individuals lacking this site. We have previously shown that this NcoI+/low TNF-alpha genotype is independently associated with increased rates of infection for liver transplant recipients.
In this study, we performed polymerase chain reaction amplification and restriction fragment length polymorphism analysis of the TNF locus from 45 renal transplant recipients to determine whether the presence of the NcoI site is associated with the frequency of rejection, infection, time to rejection or infection, and patient or graft survival.
Twenty-six recipients were typed with the NcoI+/low TNF-alpha genotype, whereas 19 recipients had the NcoI-/high TNF-alpha genotype. Age, sex, donor type, secondary immunosuppression, use of anti-lymphocyte preparations, graft ischemia time, and year of transplant were evenly distributed in the two groups. There was no difference between the genotype groups in the rate of, or time to, rejection. In contrast, significantly more patients with the NcoI+/low TNF-alpha site developed infections (46% vs. 10% P=0.01). In bivari able models, each controlling for donor type, ischemia time, recipient age, use of antilymphocyte agents, and secondary immunosuppression, the NcoI+/low TNF-alpha genotype was still independently associated with increased numbers of infections (relative risk, 5.38; confidence interval, 1.20-23.8). Conclusion. We conclude that in individuals genetically predetermined to be low TNF-alpha producers, the additional inhibition of TNF-alpha production by routine immunosuppression may be excessive, rendering these individuals less able to respond to infectious stimuli. These patients may benefit from lower doses or withdrawal of corticosteroids, which are known inhibitors of TNF-alpha transcription.
[Show abstract][Hide abstract] ABSTRACT: Antimicrobial resistance, including plasmid-mediated resistance, among the species of the Bacteroides fragilis group is well documented. An analysis of the in vitro susceptibility of B. fragilis group species referred between 1995 and 1996 as well as during a 7-year (1990 to 1996), prospective, multicenter survey of over 4,000 clinical isolates of B. fragilis group species was undertaken to review trends in the percent resistance to and geometric mean MICs of the antibiotics tested. There was a trend toward a decrease in the geometric mean MICs of most beta-lactam antibiotics, while the percent resistance to most agents was less affected. Within the species B. fragilis, the geometric mean MICs showed significant (P < 0.05) decreases for piperacillin-tazobactam, ticarcillin-clavulanate, piperacillin, ticarcillin, ceftizoxime, cefotetan, and cefmetazole; a significant increase was observed for clindamycin and cefoxitin. For the non-B. fragilis species, a significant decrease in the geometric mean MICs was observed for meropenem, ampicillin-sulbactam, ticarcillin-clavulanate, piperacillin, ticarcillin, ceftizoxime, and cefmetazole; a significant increase was observed for cefoxitin. Significant increases in percent resistance were observed within the B. fragilis strains for ticarcillin and ceftizoxime and within the non-B. fragilis isolates for cefotetan. Significant increases in percent resistance among all B. fragilis group species were observed for clindamycin, while imipenem showed no significant change in resistance trends. The trend analysis for trovafloxacin was limited to 3 years, since the quinolone was tested only in 1994, 1995, and 1996. During the 7 years analyzed, there was no resistance to metronidazole or chloramphenicol observed. The data demonstrate that resistance among the B. fragilis group species has decreased in the past several years, the major exception being clindamycin. The majority of the resistance decrease has been for the beta-lactams in B. fragilis, compared to other species. The reasons for these changes are not readily apparent.
Full-text · Article · Nov 1999 · Antimicrobial Agents and Chemotherapy
[Show abstract][Hide abstract] ABSTRACT: Background. Transplantation of organs from donors who are bacteremic is controversial. We examined the outcome of recipients of solid organs from donors with bacteremia and/or fungemia at the time of organ recovery.
Methods. All organ donors from a single organ procurement organization between January 1990 and December 1996 were retrospectively analyzed. We calculated rates of transmission from bacteremic or fungemic donors to their recipients and compared the graft and patient survival rates for recipients of these organs with those for recipients of organs from nonbacteremic donors.
Results. There were 95 (5.1%) bacteremic donors from a total of 1775, from whom 212 recipients received organs. Forty-six (48%) of the bacteremic donors had pathogens in their blood. Among the 101 recipients of organs from these, no evidence of transmission could be documented. (0% transmission rate, 95% CI 0-3). The remaining 49 donors had either Staphylococcus epidermidis or other unlikely pathogens recovered from the blood. Examination of the 111 recipients of organs from these donors also found no evidence for transmission (0% transmission rate, 95% CI 0-3). Of the 212 recipients, 193 (91%) received a mean of 3.8±2.5 days of antibiotics postoperatively. The 30-day graft and patient survival for recipients of organs from bacteremic donors was not significantly different from recipients of organs from nonbacteremic donors (P=0.695 for patient survival, and P=0.310 for graft survival).
Conclusions. Organs transplanted from bacteremic donors do not transmit bacterial infection or result in poorer outcomes. Use of organs from these donors could help increase organ availability.
[Show abstract][Hide abstract] ABSTRACT: Tumor necrosis factor-alpha (TNF-alpha) is a pro-inflammatory mediator of the immune response to allogenic and infectious stimuli. Non-immunosuppressed individuals possessing a NcoI restriction enzyme site in the TNF gene locus produce less TNF-alpha in vitro and in vivo compared with individuals lacking this restriction site. We performed polymerase chain reaction amplification and restriction enzyme fragment length analysis of the TNF locus from 86 liver transplant recipients to determine if presence of the NcoI site is associated with the frequency of rejection or infection, time to rejection or infection, and patient and graft survival. We controlled for recipient primary diagnosis, age, sex, United Network for Organ Sharing status, year of transplant, type of immunosuppression, use of anti-lymphocyte agents, and graft ischemia time. Fifty-six recipients possessed the NcoI+/low TNF-alpha genotype and 30 were NcoI-/high TNF-alpha genotype. In the first year after transplant, there were no significant differences in the frequency, or time to first rejections or the overall number of rejection episodes between the two genotypes. NcoI+/low TNF-alpha genotype recipients had significantly more infections (1.52 vs. 0.87, P=0.014). In a linear regression, multivariate model controlling for all marginally significant variables, the NcoI+/low TNF-alpha genotype was still associated with significantly more infections (P=0.0031). Patient and graft survival were equal for the two groups. One implication of this study, in individuals genetically predetermined to be low TNF-alpha producers, is that additional inhibition of TNF-alpha production by routine immunosuppression may be excessive, rendering these individuals less able to respond to infectious stimuli. These patients may benefit from lower doses or withdrawal of corticosteroids.
[Show abstract][Hide abstract] ABSTRACT: Tumor necrosis factor-α (TNF-α) is a pro-inflammatory mediator of the immune response to allogenic and infectious stimuli. Non-immunosuppressed individuals possessing a NcoI restriction enzyme site in the TNF gene locus produce less TNF-α in vitro and in vivo compared with individuals lacking this restriction site. We performed polymerase chain reaction amplification and restriction enzyme fragment length analysis of the TNF locus from 86 liver transplant recipients to determine if presence of the NcoI site is associated with the frequency of rejection or infection, time to rejection or infection, and patient and graft survival. We controlled for recipient primary diagnosis, age, sex, United Network for Organ Sharing status, year of transplant, type of immunosuppression, use of anti-lymphocyte agents, and graft ischemia time. Fifty-six recipients possessed the NcoI+/low TNF-α genotype and 30 were NcoI-/high TNF-α genotype. In the first year after transplant, there were no significant differences in the frequency, or time to first rejections or the overall number of rejection episodes between the two genotypes. NcoI+/low TNF-α genotype recipients had significantly more infections (1.52 vs. 0.87, P=0.014). In a linear regression, multivariate model controlling for all marginally significant variables, the NcoI+/low TNF-α genotype was still associated with significantly more infections (P=0.0031). Patient and graft survival were equal for the two groups. One implication of this study, in individuals genetically predetermined to be low TNF-α producers, is that additional inhibition of TNF-α production by routine immunosuppression may be excessive, rendering these individuals less able to respond to infectious stimuli. These patients may benefit from lower doses or with-drawal of corticosteroids.