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PubMed2004

Trends in the treatment of ductal carcinoma in situ of the breast.

BACKGROUND: An increase in incidence of ductal carcinoma in situ (DCIS) of the breast has been documented, and concerns regarding overly aggressive treatment have been raised. This study was designed to evaluate the use of surgery and radiation therapy in treating DCIS. METHODS: We used the National Cancer Institute's Surveillance, Epidemiology, and End Results database to assess treatment of patients with DCIS with no evidence of microinvasion who were diagnosed from January 1, 1992, through December 31, 1999. We assessed the rates of mastectomy, breast reconstruction, radiation therapy after lumpectomy, and axillary dissection. Associations were analyzed by logistic regression. RESULTS: During the study period, 25 206 patients met selection criteria. The incidence of DCIS dramatically increased with time; however, the incidence of comedo lesions did not change. The rate of mastectomy decreased from 43% in 1992 to 28% in 1999, after controlling for age, race, tumor size, comedo histology, and geographic location. However, because of the increase in the diagnosis of DCIS, the age-adjusted incidence of mastectomy for DCIS in the population did not change (7.8 per 100 000 women in 1992 and 1999). Almost half the patients undergoing lumpectomy did not undergo radiation therapy (55% in 1992 and 46% in 1999); in those with comedo histology, 33% did not undergo radiation therapy after lumpectomy, even in 1999. Overall, patients were less likely to have axillary dissection over time (34% in 1992 versus 15% in 1999), yet the rate of axillary dissection was still high (30%) in patients undergoing mastectomy in 1999. Large, statistically and clinically significant variation by geographic location was found in treatment. CONCLUSIONS: Treatment of DCIS changed in a clinically significant fashion between 1992 and 1999. Throughout this study, many patients were found to undergo aggressive surgical therapy, including mastectomy and axillary dissection, whereas others appeared to be undertreated, e.g., not receiving radiation therapy after lumpectomy, even in the presence of adverse histologic features. Variation in demographic and geographic factors indicates that at least some of these treatment differences reflect individual and institutional practice patterns that may be modifiable.

Adult↗
PubMed1990

Informed consent and the "medical student psychiatrist".

The involvement of medical students in the clinical assessment of psychiatry patients raises concerns that have ethical and possibly legal implications. Responses to a 1986 questionnaire by 91 departments of clinical psychiatry in U.S. medical schools reveal that a substantial proportion (29.3%) of these departments were not fully compliant with established guidelines for obtaining informed consent from patients for students' participation in the patients' assessment and psychiatric care. Medical educators in psychiatry should recognize the importance of consent as a topic in the educational process and should establish policies that correct the discrepancies between institutional practices and informed consent guidelines.

Disclosure↗
PubMed1992

Bacteriology, drug stability and exchange of percutaneous delivery systems and antibacterial filters in long-term intrathecal infusion of opioid drugs and bupivacaine in "refractory" pain.

OBJECTIVE: To provide a basis for recommendations on the exchange of containers (syringes and cassettes) and antibacterial filters, and for choice of administration device in patients with "refractory" pain treated with long-term percutaneous intrathecal (IT) infusions of opioid (morphine or buprenorphine) and bupivacaine mixtures. DESIGN: Prospective, cohort, nonrandomized control trial-case series, with consecutive sample, no standard criterion, and cost-benefit analysis. SETTING: Tertiary care center, institutional practice as well as hospitalized and ambulatory care. PATIENTS: Eighty-nine (51 women and 38 men); 81 with malignant pain and 8 with benign "refractory" pain. INTERVENTIONS: (a) The chemical stability of the drugs in the containers during 30 days. (b) The results of bacteriologic culture of the residual volumes of the analgesic mixtures from used and reused (1-16 times) syringes (n = 135) and cassettes (n = 258), and of 5 ml of sterile isotonic saline filtered through the used Millipore filters (n = 149). The bacteriologic samples from the 89 patients were taken after 1-40 (median = 7), 1-86 (median = 20), and 5-78 (median = 31) days of IT treatment, respectively. MAIN OUTCOME MEASURES: Chemical stability: buprenorphine and bupivacaine concentrations-liquid chromatography; morphine concentrations--gas chromatography. Bacteriologic cultures: standard laboratory procedures. The hypothesis (repeated use of the infusion systems and their exchange once a month does not significantly affect drug concentrations or increase the infection risk) was elaborated before data collection began. RESULTS: The bupivacaine-opioid mixtures were found to be chemically stable within 3-10% of the original doses up to 30 days. Seventeen cultures (from five syringes, six cassettes, and six filters) in 13 patients (having no signs of meningeal infection) were found to be colonized with Staphylococcus aureus (n = 4), coagulase negative staphylococci (n = 7), viridans streptococci (n = 3), Neisseria sp (n = 4), Corynebacterium sp (n = 4), Enterobacter sp (n = 2), Klebsiella sp (n = 3), gram-negative bacilli (n = 1), and yeasts (n = 2). The place of IT treatment, its duration, and patient-related infection risk factors (age; malignancy; diabetes; presence of a colostomy, pyelostomy, or indwelling urinary catheter; and the presence and location of infection foci) were not related to the results of the cultures. However, 9 of the 17 positive cultures came from patients with skin ulcers, a notable incidence. The positive cultures had no connection with the cultured item, its in-use duration, the number of times of reuse, the analgesic drugs used, their concentrations or the presence of preservatives (sodium metabisulfite and sodium edetate), or the antiseptic agent (70% ethanol or 0.5% chlorhexidine gluconate) used during bacteriologic sampling. The bacterial growth was sparse in 14 and massive in 3 of the 17 positive cultures. One item (filter) from one patient with meningitis was sterile. CONCLUSIONS: In our population, exchange of the infusion systems when they are empty (within 1 month) and of the antibacterial filters once a month does not appear to affect the concentrations of, or increase the infection risk from, the opioid-bupivacaine mixtures. The risk of bacterial contamination/colonization of the syringes from syringe drivers does not seem to be higher than that of cassettes from external portable pumps.

Adolescent↗
PubMed1995

Complications of intrathecal opioids and bupivacaine in the treatment of "refractory" cancer pain.

OBJECTIVE: To test the concept that externalized tunneled intrathecal catheters lead to a high risk of complications, such as meningitis and epidural abscess, and therefore should not be used for durations of intrathecal pain treatment of > 1 week. DESIGN: Prospective, cohort, nonrandomized, consecutive, historical control trial. SETTING: Tertiary care center, institutional practice, hospitalized and ambulatory care. PATIENTS: Two hundred adults (107 women, 93 men) with refractory cancer pain treated for 1-575 (median, 33; total, 14,485) days; 79 patients were treated at home for 2-226 (median, 36; total, 4,711) days. All patients had died by the close of the study. INTERVENTIONS: Insertion of intrathecal tunneled nylon (Portex) catheters (223 in 200 patients) with Millipore filters. The catheter hubs were securely fixed to the skin with steel sutures. Standardized care after insertion: (a) daily phone contact with the patients, their families, or the nurses in charge; (b) weekly dressing change at the tunnel outlet by the nurses; (c) refilling of the infusion containers by the nurses; (d) exchange of the infusion systems when empty (within 1 month) and of the antibacterial filter once a month by specially instructed Pain Department nurses. All contact between the connections of the syringes, cassettes, and needles with the operator's hands was carefully avoided during filling and refilling of the infusion containers and exchange of the antibacterial filters; no other aseptic precautions were taken. MAIN OUTCOME MEASURES: We recorded the rates of perfect function and complications of the systems. The rates of complications recorded in this study with externalized tunneled intrathecal catheters are discussed and compared with the rates reported in the literature with externalized (tunneled and non-tunneled) epidural and intrathecal catheters, as well as with internalized (both epidural and intrathecal) catheters connected to subcutaneous ports, reservoirs, and pumps. RESULTS: The following rates (as a percentage of number of patients) of perfect function and complications of the systems were recorded (the ranges of rates reported in the literature are given in parentheses): perfect function of the system, 93% (31-90%); accidental injury of an unknown epidural tumor followed by an epidural hematoma, 0.5% (0-6%); skin breakdown at the insertion site, 2% (2-50%); postdural puncture headache, 15.5% (10%); external leakage of CSF, 3.5% (4-27%); CSF hygroma ("pseudomeningocele"), 1.5% (4-6.25%); hearing loss and Ménière-like syndrome, 0% (12%); pain on injection, 0% with continuous infusion and 4.5% with intermittent injections (3-36% with intermittent injections); catheter tip dislodgement, 1.5% (6-33%); catheter (system) occlusion, 1% (3-12%); accidental catheter withdrawal, 4% (3-22%); catheter (system) leakage, 1.5% (2.1-26.6%); all mechanical complications, 8.5% (10-44%); local (catheter entry site) infection, 0.5% (2-33%); catheter track infection, 0% (6-25%); epidural abscess, 0% (0.6-25%); meningitis, 0.5% (1-25%); systemic infection, 0% (3%); incidence of all infections (n/treatment days), 1/7,242 (1/168-1/2,446). CONCLUSIONS: In our population and with the technique of insertion and care reported here, the use of externalized tunneled intrathecal catheters has not been associated with higher rates of complications when compared with earlier reported rates of externalized epidural catheters and internalized (both epidural and intrathecal) catheters connected to subcutaneously implanted ports, reservoirs, and pumps. The opinion that the use of externalized tunneled intrathecal catheters should be restricted only to patients who need pain treatment for < 1 week (because of the potential risk of infection, particularly meningitis and epidural abscess) is unfounded.

Adolescent↗
PubMed1998

Efficacy and technical complications of long-term continuous intraspinal infusions of opioid and/or bupivacaine in refractory nonmalignant pain: a comparison between the epidural and the intrathecal approach with externalized or implanted catheters and infusion pumps.

OBJECTIVE: To compare efficacies, failure rates, and technical complication rates of intraspinal treatments in patients with "refractory" nonmalignant pain conditions in relation to the approach (epidural/intrathecal), the drug (opioid/opioid-bupivacaine or bupivacaine), and the type of system used (externalized/internalized). In these comparisons, recent data from a companion paper (Nitescu et al., Clin J Pain 1998;14:17-28) were used as a reference to be compared with data from a literature review of different intraspinal treatment modalities in nonmalignant pain. DESIGN: Prospective, cohort, nonrandomized, consecutive trial. SETTING: Tertiary care center, institutional practice, hospitalized, and ambulatory care. PATIENTS: Five groups according to treatment modality: (a) externalized, long-term intrathecal nylon catheters, connected to external, electronic infusion pumps (companion paper), n = 90; (b) internalized, long-term intrathecal catheters (Silastic) connected to implanted SynchroMed pumps, n = 330 (literature review); (c) externalized, "short-term" epidural catheters for "temporary" infusions, n = 565 (literature review); (d) externalized, long-term epidural catheters, n = 50 (literature review); (e) internalized, long-term epidural catheters, n = 111, connected to implanted systems: Port-A-Cath injection ports, n = 58; Infusaid pumps, n = 46; and SynchroMed pumps, n = 7 (literature review). INTERVENTIONS: In reviewing the literature, we found 21 studies that reported on the intraspinal (epidural or intrathecal) administration of opioids with or without local anesthetics (usually bupivacaine). These studies were analyzed with respect to the rates of the variables satisfactory pain relief (efficacy), failures, and technical complications. A rate is the number of observations of a variable divided by the number of patients or the number of catheters or infusion systems, as logically indicated (e.g., the numbers of complications, such as epidural abscess and meningitis, were related to the number of patients and those of catheter occlusion or leakage to the number of the catheters). The variables were expressed as the means of the rates of a variable from studies belonging to various treatment modalities: approach (epidural vs. intrathecal), duration (short vs. long term), drugs administered intraspinally (opioid vs. opioid and/or local anesthetic), and type of infusion system (externalized vs. internalized). Further, the sums of all observations of one variable in different studies with various treatment modalities were related to the corresponding sums of the patients (alternatively, catheters or implanted devices). The proportions of these sums were tested for significance in relation to treatment modality. MAIN OUTCOME MEASURES: Comparative rates of successful intraspinal treatment and its failures and complications. RESULTS: (a) The intrathecal approach, compared with the epidural approach, was associated with higher rates of satisfactory pain relief for both externalized (86/90, 95% vs. 17/40, 42.5%, p < .0001) and internalized (295/336, 89% vs. 33/56, 59%, p < .0001) catheters; higher rates of treatment failures with externalized epidural catheters than with internalized intrathecal catheters (24/47, 51%, vs. 36/338, 11%, p < .0001); lower rates of treatment failures with internalized intrathecal catheters than with internalized epidural catheters (36/338, 11% vs. 29/76, 38%, p < .0001); higher rates of system replacement with internalized epidural catheters than with internalized intrathecal catheters (23/32, 72% vs. 6/49, 12%, p < .0001; higher rates of system removal with internalized epidural catheters than with internalized intrathecal catheters (22/49, 45% vs. 5/49, 10%, p < .001); higher rates of catheter-related complications with epidural than with intrathecal catheters (dislodgement 13/126, approximately 10% vs. 6/150, 4%, p < .05; leakage 5/51, approximately 10% vs. 1/116, 0.9%, p < .05; obstruction 2

Anesthetics, Local↗
PubMed1998

Continuous infusion of opioid and bupivacaine by externalized intrathecal catheters in long-term treatment of "refractory" nonmalignant pain.

OBJECTIVE: To explore the possibility of obtaining pain relief by continuous intrathecal infusion of bupivacaine and opioid in patients with intractable nonmalignant pain. DESIGN: Prospective, cohort, nonrandomized, consecutive trial. SETTING: Tertiary care center, institutional practice, hospitalized, and ambulatory care. PATIENTS: A total of 90 patients, 40 men and 50 women, 20 to 96 years old (median, 70 years), with various nonmalignant "refractory" pain conditions lasting for 0.3 to 50 years (median, 3 years) with nociceptive (n = 9), neurogenic/neuropathic (n = 17), and mixed pain (n = 64) were consecutively included in the study when (a) the pain dominated their lives totally, (b) other methods failed to provide acceptable pain relief, and (c) unacceptable side effects from opioids had occurred. Moribund patients and those with overt psychoses at the time of the assessment were excluded from the study. INTERVENTIONS: (a) Insertion of externalized, tunnelled intrathecal catheters (101 in 90 patients). (b) Intrathecal infusion of opioid (morphine 0.5 mg/ml, or buprenorphine 0.015 mg/ml, and/or bupivacaine 4.75-5.0 mg/ml) from external electronic pumps was started in the operating room at a basic rate of 0.2 ml/hour, with optional bolus doses (0.1 ml 1-4 times/hour) by patient-controlled analgesia (PCA). Thereafter, the daily volumes were tailored to give the patients satisfactory to excellent (60-100%) pain relief, with acceptable side effects from the infused drugs, by increase or decrease of the basic rates and/or of the bolus doses, and their timing. (c) Supervision of the patients for 24 hours after catheterization in the postoperative ward. (d) Daily phone contact with the patients, their families, or the nurses in charge. (e) The patients had ad libitum access to nonopioid analgesics/sedatives and to opioids administered by various routes, until they obtained satisfactory pain and anxiolytic relief. MAIN OUTCOME MEASURES: (a) Pain intensity (visual analog scores 0-10) and pain relief (0-100%). (b) Daily dosages (opioid administered by intrathecal and other routes, and intrathecal bupivacaine). (c) Scores (0-5) of nonopioid analgesics, gait and ambulation, duration of nocturnal sleep, and (d) rates of adverse effects. RESULTS: During the intrathecal period [range, 3-1,706 days; median, 60 days; totaling 14,686 days, 7,460 (50% of which were spent at home)], 86 patients (approximately 95%) obtained acceptable (60-100%) pain relief. The nocturnal sleep duration increased from <4 to 7 hours (median values), nonopioid analgesic and sedative daily consumption became approximately two times lower, whereas the gait ability and ambulation patterns remained practically unchanged. Five patients still had ongoing treatment after durations of 30 to 1,707 (median, 206) days at the close of the study. In the remaining 85 patients, the intrathecal treatment was terminated because of patients' death (n = 23), replacement of the intrathecal treatment by dorsal column stimulation (n = 1), pain resolution (n = 32), refusal to continue the intrathecal treatment (n = 19), lack of cooperation due to delirium or to manipulation of the pump (n = 8), and loss of efficacy of the intrathecal treatment (n = 2). Thus, in the long run, the intrathecal treatment failed in 29 of the 85 patients with terminated treatment (34%). The principal side-effects and complications, except those attributed to the dural puncture, the equipment, and the long-term catheterization of the subarachnoid space, which are presented separately, were severe bradypnea (n = 1), transient paresthesiae (n = 26), short-lasting pareses (n = 16), temporary urine retention (n = 34), episodic orthostatic arterial hypotension (n = 11), and attempted suicide (n = 5, 3 of which were successful). No neurologic sequelae or death could be attributed to the intrathecal procedure. (ABSTRACT TRUNCATED)

Activities of Daily Living↗
PubMed1998

Long-term home treatment with epidural analgesia does not affect later spinal cord stimulation in patients with otherwise intractable angina pectoris.

OBJECTIVE: The only way some patients with intractable angina pectoris can endure the daily pain is by using opiates. Epidural morphine or spinal cord stimulation (SCS) for out-patients is a possibility for this patient group. The aim of this study was to determine whether patients previously treated with epidural injections had more frequent electrode migration, higher stimulation needs, and less effect of SCS treatment. DESIGN: A prospective, nonrandomized study with a 4-year follow-up period. SETTING: Department of Anaesthesia, Pain Section. A referral center in institutional practice. Ambulatory care. PATIENTS: The patient group comprised 53 patients; all had been treated daily with opiates. A total of 26 patients had epidural catheters for a mean time of 1 year before SCS. All patients had intractable angina pectoris. For these patients, further angioplasty or coronary bypass surgery was not technically possible. Even with maximal medication, it was impossible to cope with the patients' angina pectoris, and the only way the patients could endure the daily pain was by using opiates. Therefore, alternative therapies were considered to give these patients palliation. INTERVENTION: SCS with epidural electrodes stimulating paresthesia in the area where angina is perceived. MAIN OUTCOME MEASURE: Difference for the patients previously treated with epidural catheters in stimulation amplitude, frequency of electrode migration, and effect of SCS. RESULTS: Stimulation demand (p = 0.09), frequency of electrode migrations (p = 0.46), and pain-reducing effect (p = 0.16) were not different for the group of patients previously treated with epidural catheters for longer periods (1-36 months). CONCLUSIONS: SCS in patients previously treated with epidural catheters has an effect equal to that in other patients.

Aged↗
PubMed2002

Acute severe asthma: differences in therapies and outcomes among pediatric intensive care units.

OBJECTIVE: To determine differences in therapies and outcomes among pediatric intensive care units for patients with acute severe asthma. DESIGN: Retrospective cohort study. SETTING: Eleven pediatric intensive care units participating in the Pediatric Intensive Care Evaluations. PATIENTS: Patients were 1528 children with a primary diagnosis of asthma. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We studied severity of illness, length of stay, and use of invasive interventions. The patients at the centers had similar median physiologic measures of illness and Pediatric Risk of Mortality III scores. The patients received a wide range of invasive interventions depending on institution, including mechanical ventilation (3% to 47%), arterial catheter placement (4% to 46%), central venous catheter (2% to 51%), and determination of a blood gas (24% to 70%). At institutions where mechanical ventilation was used more commonly (>20%, high use), intensive care and hospital stays were longer for asthmatic patients regardless of mechanical ventilation requirement compared with centers with lower use of mechanical ventilation. The status of "high-use center" was an independent predictor for intensive care stay (p = .005) and hospital length of stay (p = .017) as well as duration of mechanical ventilation (p = .014) after adjustment for age, degree of hypercarbia, maximal respiratory rate, use of an arterial catheter, and Pediatric Risk of Mortality III scores among ventilated children. CONCLUSIONS: We found that use of invasive interventions including mechanical ventilation and vascular monitoring varied greatly by institution. Centers with higher use of mechanical ventilation had longer median intensive care stay and hospital stays. Pediatric asthma management for acute severe asthma may be improved by clear elucidation of the institutional practices where fewer invasive interventions were used to achieve better outcomes.

Child↗
PubMed2002

Incidence and natural history of below-knee deep venous thrombosis in high-risk trauma patients.

BACKGROUND: Venous thromboembolic disease remains a difficult problem in the trauma patient population. The purpose of this study was to delineate the incidence and natural history of below-knee deep venous thrombosis (BKDVT) in high-risk trauma patients. METHODS: Patients were stratified into risk categories (low, high, or very high) for deep venous thrombosis on the basis of an institutional practice management guideline and known risk factors. All at-risk patients received either sequential compression devices (SCDs) or subcutaneous heparin (SQH) compounds, and high-risk patients also underwent weekly surveillance by duplex scanning. Very-high-risk patients had prophylactic inferior vena cava (IVC) filter placement. This prospective, observational study examines the duplex results on all high-risk patients. Data regarding method of prophylaxis, the incidence of proximal propagation on serial duplex examinations, and changes in management (anticoagulation or IVC filter placement) were collected on the high-risk patients who developed a BKDVT. RESULTS: Between March 1997 and June 2001, 601 patients were stratified into the high-risk category and underwent a total of 1,109 duplex examinations. Eighty-five patients (14.1%) had 113 BKDVTs. These patients underwent a total of 212 duplex examinations; all patients developed their BKDVTs within 34 days. Weekly incidence was 40 (47.1%), 25 (29.4%), 15 (17.6%), 1 (1.2%), and 4 (4.7%) for weeks 1 through 5, respectively. SCDs, SQH compounds, and SCDs with SQH compounds were used on 73, 3, and 9 patients, respectively. In 4 of 85 (4.7%) patients, the BKDVT propagated proximally to an above-knee location in 4 to 8 days. Two of these patients were anticoagulated, and two underwent placement of an IVC filter. One patient (1.2%) with a BKDVT that had not propagated on duplex study developed a pulmonary embolus. CONCLUSION: Patients identified as high-risk by our practice management guideline had a 14.1% incidence of a BKDVT; 94.1% were diagnosed within the first 3 weeks of hospitalization. Proximal propagation occurred in 4.7% and led to changes in management. Serial duplex examination of the BKDVT alone, rather than systemic anticoagulation or IVC filter placement, appears to be a reasonable treatment alternative.

Adolescent↗
PubMed1994

Breakpoints and continuities: a case study of reactive change.

In 1987, nursing administrators effected radical changes on a pediatric psychiatry ward: A bachelor's degree in nursing science became mandatory for nursing staff, family systems nursing was introduced, and postdischarge nursing follow-up was instituted. To convey how they accomplished the changes, a case history of change on the ward is presented. It suggests that there were many driving forces. Factors most important to nursing's success included a strong vision of nursing, sufficient pain or discomfort to motivate change, the ability to recognize and seize opportunities, and the linking of change to existing institutional practices, policies, and values.

Child↗
PubMed2004

Transitional cell carcinoma of the bladder following augmentation cystoplasty for the neuropathic bladder.

PURPOSE: Cancer following augmentation cystoplasty is a recognized risk factor. The procedure has only gained popularity in pediatric urology within the last 25 years, limiting the population being studied by statistical power and the lack of long-term followup. The majority of reported cases of post-augmentation malignancy have occurred in adults with multiple risk factors. Currently the most common indication for augmentation cystoplasty in children and adolescents is neuropathic bladder. We review 3 cases of transitional cell carcinoma (TCC) following augmentation cystoplasty in this unique population with no additional risk factors for bladder cancer. MATERIALS AND METHODS: We reviewed our clinical database of children and adolescents who underwent bladder augmentation since 1978 to evaluate the incidence of cancer. This study represents a captured population within a single institutional practice. There were 483 cases entered into the database, and particular attention was paid to 260 augmentations with at least 10 years of followup. We reviewed medical history, clinical outcomes, cancer risk factors, augmentation type and pathology of the 3 patients who presented with TCC after augmentation cystoplasty. RESULTS: Three patients presented with grade 2 to 3 TCC following bladder augmentation, all of whom underwent exploratory laparotomy and eventually died of metastatic disease. No patient had a history of smoking exposure greater than 10 packs per year or other known risk factors for bladder cancer. Two patients had an ileocecal augmentation and 1 had a cecal augmentation for neuropathic bladder. Patient age at augmentation was 8, 20 and 24 years, and age at diagnosis of TCC was 29, 37 and 44 years, respectively. Mean time from augmentation to TCC was 19 years. Assuming a 10-year lag period before the risk of cancer, in at least 1.2% of bladder augmentation cases in our database cancer has developed. CONCLUSIONS: This study supports the hypothesis that bladder augmentation appears to be an independent risk factor for TCC, with a lag time of less than 20 years. We recommend endoscopic surveillance of all patients with a history of bladder augmentation beginning 10 years after initial surgery.

Adult↗
PubMed2005

Contribution of the prostate limits the usefulness of survivin for the detection of bladder cancer.

PURPOSE: We determined if urinary survivin is influenced by the prostate and analyzed survivin levels in a healthy control population. MATERIALS AND METHODS: This was a blinded, retrospective analysis of frozen urine samples. Three groups were designated. Group 1 patients were diagnosed with prostate cancer and samples were collected immediately prior to radical retropubic prostatectomy. Group 2 patients had already undergone radical retropubic prostatectomy at least 3 months prior to providing a urine sample. Group 3 comprised healthy controls. Groups 1 and 2 patients were recruited at an institutional practice. Group 3 patients were recruited from the local community. RESULTS: The frequency of high survivin scores was much lower in patients who did not have a prostate (p < 0.0002). The survivin score was 2 in 35% and 44% of the patients in groups 1 and 3, respectively, while only 9% of those in group 2 had a survivin score of 2 (p < 0.0002). Of healthy controls 50% had a false-positive survivin score. Urinary survivin predicted prostate cancer poorly with 52% sensitivity and 50% specificity, and it did not predict any biological features of prostate cancer. CONCLUSIONS: Urinary survivin markedly decreases after prostatectomy. There is a 50% false-positive rate when using urinary survivin in controls. These 2 features make urinary survivin a poor bladder cancer biomarker.

Aged↗
PubMed2006

Nasal sound analysis: a new method for evaluating nasal obstruction in allergic rhinitis.

OBJECTIVE: Current measurements of nasal obstruction are unreliable and may be improved with the development of new techniques. The effectiveness of odiosoft-rhino (OR) in the evaluation of nasal obstruction was investigated in a blind comparison at a referral center, institutional practice. PATIENTS: Forty-eight patients with perennial allergic rhinitis and 52 healthy subjects were studied. Nasal endoscopic examination, acoustic rhinometry (AR), and OR were performed and symptom scores compared. MAIN OUTCOME MEASURE: Assessment of nasal blockage with OR method was the main outcome measure. RESULTS: Using the OR technique, significant differences were observed between the patient and control groups. OR data correlated with symptom scores and endoscopic examination. However, this was not observed with AR. A 15.5-dB cutoff point for the left side and 14.5 dB cutoff point for the right side at the 2,000 to 4,000 Hz frequency interval resulted in 93.8% sensitivity and 92.3% specificity and 72.9% sensitivity and 80.8% specificity, respectively. A 8.5-dB cutoff point for the left and right sides at the 4,000 to 6,000 Hz frequency interval resulted in 87.5% sensitivity and 80.8% specificity and 70.8% sensitivity and 78.8% specificity, respectively. CONCLUSION: OR is a simple, noninvasive test for assessing nasal obstruction. The OR technique can detect nasal obstruction with high sensitivity and specificity, and these findings correlate with symptoms and physical examination.

Adult↗
PubMed2006

Healthcare restructuring and hierarchical alignment: why do staff and managers perceive change outcomes differently?

PURPOSE: Healthcare organizations have undergone major change efforts in the past decade. Sustained change is related to continued alignment among organizational participants and may fail with incongruent perceptions of change. This study identifies factors contributing to the alignment in perceptions of organizational change outcomes between executives and all other employees. METHODOLOGY: The sample included 10 hospitals with survey responses from 421 executives and other employees. Using hierarchical linear modeling (HLM), perceptual alignment was modeled at the first level as a function of goal commitment, goal clarity, goal acceptance, goal specificity, staff participation, available skill set, and knowledge and at the second level as organizational size. FINDINGS: Descriptive statistics showed employee perception of outcomes differed among personnel levels. HLM results showed that goal specificity, appropriate staff training, reward incentives, effective communication, information sharing, and organization's ability to sustain changes induced perceptual alignment in change outcomes. Staff involvement in designing change efforts increased perceptual misalignment, whereas involvement during implementation and maintenance phases increased alignment. RESEARCH LIMITATIONS: This research uses cross-sectional data from 10 hospitals. Data were gathered from surveys that may have recall bias as hospitals were surveyed at different times after the implementation of their restructuring. PRACTICAL IMPLICATIONS: Our findings enhance the understanding of processes and mechanisms that enable healthcare organizations to align organizational participants' efforts during change. Results suggest that decision-makers should create incentives to encourage innovative practices, institute effective communication mechanisms, selectively disseminate information, and involve participants in implementing and maintaining changes to achieve intended outcomes. ORIGINALITY/VALUE OF ARTICLE: This article provides unique insight into the importance and causes of organizational alignment after major restructuring. Too often, organizations' change efforts fail after implementation. Effective change requires continued effort and alignment to embed the desired changes.

Attitude of Health Personnel↗
PubMed2005

A randomized trial of three renal transplant induction antibodies: early comparison of tacrolimus, mycophenolate mofetil, and steroid dosing, and newer immune-monitoring.

BACKGROUND: New trends in immunosuppression in clinical transplantation include the use of antibody induction agents in protocols that emphasize reduction or avoidance of steroids and calcineurin inhibitors. METHODS: In a randomized trial using three different antibody induction agents in 90 first renal transplant recipients from cadaver donors, group A received Thymoglobulin, group B received Alemtuzumab, and group C received Daclizumab. Maintenance immunosuppression included tacrolimus and mycophenolate in all three arms, and methylprednisolone in groups A and C only (standard clinical institutional practice). The targeted trough level of tacrolimus was between 8 and 10 ng/mL for groups A and C, respectively, with a targeted mycophenolate dose of 1 g twice daily. However, in group B, the target tacrolimus trough level was 4 to 7 ng/mL to reduce long-term nephrotoxicity, with 500 mg twice-daily doses of mycophenolate, without steroid maintenance. RESULTS: In this 15-month median postoperative interval report, there were no notable differences in demographics and patient and graft survivals. Acute rejection rates at 1 year were equivalent, that is, 5 of 30 in all three groups (16.6%). In group B, there was slightly lower renal function at 1 month, but no difference at 1 year. There was also significantly more leukopenia, but a greater percentage of T-regulatory cells and number of Fox-P3 mRNA copies by flow cytometry and semiquantitative polymerase chain reaction analysis, respectively, in group B. CONCLUSIONS: This preliminary analysis indicates that 80% of the patients in group B remained steroid-free 1 year postoperatively, with lower tacrolimus trough levels and no difference in other adverse events.

Adult↗
PubMed1994

Getting dressed in the early morning: styles of staff/patient interaction on rehabilitation hospital wards for elderly people.

This paper presents findings from a study of the nursing role in rehabilitation hospital wards for elderly people and focuses on early morning dressing; this is a microcosm of service delivery but it illustrates the way in which institutional practices impinge on patient experiences and highlights areas which warrant attention for the future development of rehabilitation services for elderly people in hospital. The reported findings are drawn from a non-participant structured observational study of 'early morning rising' on rehabilitation wards for elderly people.

Activities of Daily Living↗