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Biomedical subjects

M Gold

Publications and source records attributed to M Gold.

At least 19 recordsLinked to original sources
PubMed2007

Anger in palliative care: a clinical approach.

Anger in patients and families is a common problem in the care of persons with advanced disease. Whereas it is widely accepted that anger may be a justifiable reaction to significant illness and loss, it frequently creates difficulties for the doctors involved in care. In particular, there is often a personal impact on the doctor at whom anger is directed. This paper examines results of qualitative research with palliative care workers in the context of the broader published literature and the authors' clinical experiences. The ability to interact effectively with angry patients is a skill that is often learned with experience and is extremely useful in both transforming the patients' reaction into a more creative emotion and in developing a therapeutic relationship. Despite conscientious efforts, however, a few patients continue to be angry. A practical approach to anger, useful for the clinician directly involved in care, is outlined along with some strategies to adopt in the face of persistent anger.

Adaptation, Psychological↗
PubMed2006

Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children.

BACKGROUND: Concern exists that the prolonged application of immunomodulators to treat atopic dermatitis may cause systemic immunosuppression. AIMS: In a 7-month, multicentre, randomised, controlled trial, we investigated the equivalence of response to vaccination against meningococcal serogroup C disease with a protein-conjugate vaccine in children (2-11 years) with moderate to severe atopic dermatitis, by applying either 0.03% tacrolimus ointment (TAC-O; n = 121[corrected]) or a hydrocortisone ointment regimen (HC-O; n = 111). METHODS: TAC-O was applied twice daily (bid) for 3 weeks, and thereafter daily until clearance. 1% hydrocortisone acetate (HA) for head/neck and 0.1% hydrocortisone butyrate ointment for trunk/limbs was applied bid for 2 weeks; thereafter HA was applied bid to all affected areas. At week 1, patients were vaccinated with protein-conjugate vaccine against meningococcal serogroup C, and challenged at month 6 with low dose meningococcal polysaccharide vaccine. The control group (44 non-atopic dermatitis children) received the primary vaccination and challenge dose. Assessments were made at baseline, weeks 1 and 5, and months 6 and 7. The primary end point was the percentage of patients with a serum bactericidal antibody (SBA) titre > or = 8 at the week 5 visit. RESULTS: The response rate (patients with SBA titre > or = 8) was 97.5% (confidence interval (CI) approximately 97.3 to 100), 99.1% (94.8 to 100) and 97.7% (93.3 to 100) in the TAC-O, HC-O and control groups, respectively. CONCLUSIONS: The immune response to vaccination against meningococcal serogroup C in children with atopic dermatitis applying either 0.03% TAC-O or HC is equivalent. Ointment application does not affect the immediate response to vaccination, generation of immune memory or humoral and cell-mediated immunity.

Administration, Topical↗
PubMed2006

A prospective cohort study of health outcomes following whiplash associated disorders in an Australian population.

OBJECTIVE: To define health outcomes of whiplash associated disorders (WAD) at three months, six months, and two years after injury and to examine predictors of these outcomes. DESIGN: Prospective cohort study. SETTING: New South Wales, Australia. SUBJECTS: People with compensable motor crash injuries who reported whiplash as one of their injuries. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Functional Rating Index (FRI), Short Form 36 (SF-36) at three months, six months, and two years after injury, ascertained by telephone interview. RESULTS: At three months, 33.6% of the cohort was recovered (as defined by FRI<or=25), increasing marginally at six months (38.9% recovered), but more significantly at two years (51.7% recovered, p = 0.001). The mean physical component score of the SF-36 improved at each time point (p = 0.002), while the mean mental component score did not (p = 0.59). Predictors of recovery at two years (as defined by global perceived effect) included a lower FRI index at baseline (p = 0.001) and closure of the claim at two years (p = 0.02). CONCLUSION: Whiplash injury had a large effect on the health of this Australian cohort of whiplash sufferers, with only 50% of the cohort recovered at two years. Physical measures of health appear to improve over time, whereas mental measures of health did not. Despite this, this cohort is largely able to participate in activities and work at two years. Prevention of chronic disability may lie with concentration of resources to those who score highly on the FRI at baseline. In addition, chronic psychological ill health may be prevented by directing treatment to those with poor scores on sensitive measures of psychological ill health at baseline.

Adolescent↗
PubMed2004

ASCIA guidelines for prevention of food anaphylactic reactions in schools, preschools and child-care centres.

These guidelines have been developed by the anaphylaxis working party of the Australasian Society of Clinical Immunology and Allergy to provide advice for minimizing the risk of food-induced anaphylaxis in schools, preschools and child-care centres. The guidelines outline four steps for the prevention of food anaphylactic reactions in children at risk and food policy measures specific to school age and preschool age children.

Age Factors↗
PubMed2003

Relief of acute low back pain with diclofenac-K 12.5 mg tablets: a flexible dose, ibuprofen 200 mg and placebo-controlled clinical trial.

OBJECTIVE: To assess efficacy and safety of diclofenac-K 12.5 mg tablets in the treatment of acute low back pain (low back pain). MATERIAL/METHOD: A multiple dose, double-blind, double-dummy, randomized, placebo-controlled, parallel group trial compared diclofenac-K (12.5 mg; n = 124) with ibuprofen (200 mg; n = 122) and placebo (n = 126) in patients with moderate-to-severe acute low back pain. The treatment consisted of an initial dose of 2 tablets followed by 1 or 2 tablets every 4-6 hours as needed (maximum 6 tablets/day) for 7 days. The primary efficacy outcome for the initial dose was TOTPAR-3, the summed total pain relief over the first 3 hours. Secondary initial dose outcomes included TOTPAR-6, summed pain intensity differences SPID-3 and SPID-6, time to rescue medication or remedicate, and the End of First Dose global efficacy assessment. The primary efficacy outcome for the flexible multiple dosing regimen was the End of Study global efficacy assessment. Secondary outcomes for multiple dosing included time to rescue medication over the entire study, the End of Day global efficacy assessments (daily over Days 1-7), pain intensity differences on the VAS measured at Visit 2 and 3, and change in Eifel algofunctional index. Safety/tolerability was assessed by recording adverse events. RESULTS: Diclofenac-K 12.5 mg demonstrated superiority vs placebo on the primary efficacy parameter and almost all secondary initial dose outcomes. With respect to the initial dose, diclofenac-K 12.5 mg was also significantly superior to ibuprofen 200 mg on SPID-3. Ibuprofen 200 mg was superior to placebo only on the End of First Dose global efficacy assessment. The flexible multiple dosing regimens of diclofenac-K and ibuprofen were both significantly superior to placebo on the End of Study global efficacy assessment, time to rescue medication over the entire study period, the End of Day global efficacy assessment on Days 1-2, pain intensity difference on the VAS at Visit 3 and the Eifel algofunctional index at Visit 3 (also at Visit 2 in diclofenac-K 12.5 mg group). Both active treatments were as well tolerated as placebo. CONCLUSIONS: The flexible multiple dosing regimen of diclofenac-K 12.5 mg (initial dose of 2 tablets followed by 1-2 tablets every 4-6 hours, max. 75 mg/day) is an effective and safe treatment of acute low back pain.

Acute Disease↗
PubMed2002

National study of adverse reactions after vaccination with bacille Calmette-Guérin.

Few large prospective studies of adverse reactions after bacille Calmette-Guérin (BCG) vaccination are available. In a prospective national study of such adverse reactions among 918 subjects (aged 1 day to 54 years) over a 14-month period, 45 vaccinees (5%) reported 53 adverse reactions (23 injection-site abscesses, 14 severe local reactions, 10 cases of lymphadenitis, and 6 other reactions). Only 1% of vaccinees required medical attention. Reactions, particularly lymphadenitis, were significantly less common in infants <6 months old (but not in subjects aged > or =6 months) vaccinated by trained (vs. untrained) providers (relative risk [RR], 0.24; 95% confidence interval [CI], 0.09-0.68). Injection-site abscesses (RR, 2.96; 95% CI, 1.11-7.90) and severe local reactions (RR, 4.93; 95% CI, 1.11-21.90) were significantly more common in older vaccinees. Local reactions were more frequently reported by adult females than by adult males (RR, 7.18; 95% CI, 1.59-32.45). Adverse reactions were not significantly associated with any currently available vaccine batch, previous receipt of BCG vaccine, or concomitant administration of other vaccines.

Adolescent↗
PubMed2001

Electrical storm presages nonsudden death: the antiarrhythmics versus implantable defibrillators (AVID) trial.

BACKGROUND: Electrical storm, multiple temporally related episodes of ventricular tachycardia (VT) or ventricular fibrillation (VF), is a frequent problem among recipients of implantable cardioverter defibrillators (ICDs). However, insufficient data exist regarding its prognostic significance. METHODS AND RESULTS: This analysis includes 457 patients who received an ICD in the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial and who were followed for 31 +/- 13 months. Electrical storm was defined as > or = 3 separate episodes of VT/VF within 24 hours. Characteristics and survival of patients surviving electrical storm (n = 90), those with VT/VF unrelated to electrical storm (n = 184), and the remaining patients (n = 183) were compared. The 3 groups differed in terms of ejection fraction, index arrhythmia, revascularization status, and baseline medication use. Survival was evaluated using time-dependent Cox modeling. Electrical storm occurred 9.2 +/- 11.5 months after ICD implantation, and most episodes (86%) were due to VT. Electrical storm was a significant risk factor for subsequent death, independent of ejection fraction and other prognostic variables (relative risk [RR], 2.4; 95% confidence interval [CI], 1.3 to 4.2; P = 0.003), but VT/VF unrelated to electrical storm was not (RR, 1.0; 95% CI, 0.6 to 1.7; P = 0.9). The risk of death was greatest 3 months after electrical storm (RR, 5.4; 95% Cl, 2.4 to 12.3; P = 0.0001) and diminished beyond this time (RR, 1.9; 95% CI, 1.0 to 3.6; P=0.04). CONCLUSIONS: Electrical storm is an important, independent marker for subsequent death among ICD recipients, particularly in the first 3 months after its occurrence. However, the development of VT/VF unrelated to electrical storm does not seem to be associated with an increased risk of subsequent death.

Aged↗
PubMed2001

The solution structure of bacteriophage lambda protein W, a small morphogenetic protein possessing a novel fold.

Protein W (gpW) from bacteriophage lambda is required for the stabilization of DNA within the phage head and for attachment of tails onto the head during morphogenesis. Although comprised of only 68 residues, it likely interacts with at least two other proteins in the mature phage and with DNA. Thus, gpW is an intriguing subject for detailed structural studies. We have determined its solution structure using NMR spectroscopy and have found it to possesses a novel fold consisting of two alpha-helices and a single two-stranded beta-sheet arranged around a well-packed hydrophobic core. The 14 C-terminal residues of gpW, which are essential for function, are unstructured in solution.

Amino Acid Sequence↗
PubMed2001

The effects of pneumoperitoneum and patient position on hemodynamics during laparoscopic cholecystectomy.

BACKGROUND: The purpose of this study was to prospectively examine the combined effects of pneumoperitoneum and the reverse Trendelenberg position on cardiac hemodynamics during laparoscopic cholecystectomy. METHODS: Thirty-nine patients undergoing laparoscopic cholecystectomy as performed by a single surgeon were enrolled in the study. Hemodynamic data were collected continuously using a transthoracic bioimpedance monitor. All patients were subjected to insufflation pressures of 15 mmHg. Data were examined using mixed analysis of variance (ANOVA). RESULTS: Cardiac index fell 11% with induction of anesthesia (p < 0.05), with stroke volume decreasing 7.2% (p < 0.05). Insufflation caused significant decreases in stroke volume (SV) left ventricular end diastolic volume (LVEDV) but not cardiac index (CI). Placing the patients in the reverse Trendelenberg position caused no significant changes in these parameters. There were no significant differences between ASA (American Society of Anesthesiologists) classes I and II patients when compared to ASA III patients. CONCLUSIONS: Patients undergoing laparoscopic cholecystectomy experience significant hemodynamic depression. The effect of general anesthesia is the most profound. Insufflation of the abdomen caused more mild hemodynamic effects in our study. The addition of a reverse Trendelenberg position did not alter the patient's hemodynamic status.

Adult↗
PubMed2001

Analysis of FIGO Stage IIIc endometrial cancer patients.

OBJECTIVE: The aim of this study was to analyze FIGO Stage IIIc endometrial cancer (EC) patients to better define clinicopathologic associations, patterns of failure, and survival. METHODS: Charts were abstracted from EC patients with lymph node metastasis from 1989 to 1998. Data on clinicopathologic variables, adjuvant treatment, site of first recurrence, and survival were collected. Associations between variables were tested by chi(2) and Wilcoxon rank sums. Survival analyses were performed by the Kaplan-Meier method, and multiple regression analysis was done by the Cox proportional hazards model. RESULTS: From 607 EC patients evaluated, 47 (8%) were identified with FIGO Stage IIIc disease. All 47 underwent hysterectomy and pelvic lymph node (PLN) sampling, and 42/47 had para-aortic lymph node (PALN) sampling. Stage IIIc disease was defined by positive PLN alone in 38%, positive PLN and PALN in 41%, and positive PALN alone in 17%. Twelve of 47 also had positive peritoneal cytology and/or adnexal metastases. Grade III tumors were present in 56% and >50% myometrial invasion in 61%. No association between depth of invasion (DOI) and grade was seen, however. Nearly 1/3 of cases had papillary serous or clear cell histology. Postoperative adjuvant treatment included whole abdominal radiation (36%), pelvic radiation with (19%) and without (17%) extended field, chemotherapy (17%), and oral progestins (11%). The 3-year and 5-year survival estimates for all patients were 77 and 65%, respectively. At a median follow-up of 37 months, 5 patients are alive with disease, and 10 are dead of disease. A distant site of first recurrence was most common (21%), followed by pelvic failure (9%). Only 1 patient has had an abdominal recurrence. Univariate predictors of survival included age, DOI, and extranodal disease, but not grade, histology, or PALN involvement. For the 12 patients with nodal disease and positive cytology and/or adnexa, 3-year survival was 39% versus 93% for those patients without evidence of extranodal disease. In a multivariate analysis only DOI was an independent predictor of survival (P = 0.03). CONCLUSIONS: Once lymph node involvement occurs, the importance of additional extranodal disease increases. Consideration of substaging Stage IIIc patients based on positive adnexa or cytology is supported by the data. The extent which adjuvant treatments contributed to the 77% 3-year survival remains to be defined. The patterns of failure suggest a possible role for combined modalities in future treatments.

Adult↗
PubMed2001

Predictors of complications after inguinal lymphadenectomy.

OBJECTIVE: The aim of this study was to identify predictors of complications in patients undergoing inguinal lymphadenectomy (LND) in the treatment of vulvar carcinoma. METHODS: Clinical information was abstracted from records of patients with invasive vulvar cancer. All patients underwent LND. Closed suction drains were placed in groin incisions and removed when output was less than 30 ml/24 h. Associations between variables were studied by chi(2) and t tests. RESULTS: Sixty-seven patients undergoing 112 LND were evaluated. Eighty-eight percent of patients underwent radical vulvar surgery and LND while 12% underwent LND alone. Patients were treated with either unilateral (22) or bilateral (45) LND. Seventy-three percent received extended postoperative prophylactic antibiotics. The median duration of suction drainage was 15 days for one drain and 14 days for two drains. Early postoperative cellulitis (<30 days after surgery) developed in 35.4%, early wound breakdown in 19.4%, early lymphedema in 4.8%, and early lymphocyst formation in 13.1%. Late cellulitis (>30 days after surgery) developed in 22.2%, late wound breakdown in 3.2%, late lymphedema in 29.5%, and late lymphocysts in 5%. Patients developing early cellulitis were more likely to have early wound breakdown (P = <0.001, RR 14.2) or early lymphocyst formation (P = 0.016, RR 7.6). Type of procedure, antibiotic use, need for adjuvant therapy, and duration of suction drainage did not influence early complications. Early complications and management strategies did not predict late complications. CONCLUSIONS: Chronic lymphedema occurs in nearly 30% of patients after LND. Late complications after LND were not predicted by early complications. New strategies for prevention of chronic lymphedema are needed.

Adult↗
PubMed2001

Nodal distribution and its significance in FIGO stage IIIc endometrial cancer.

OBJECTIVE: The aim of this study was to describe the distribution of nodal disease in FIGO Stage IIIc endometrial cancer (EC) and to evaluate whether nodal distribution is related to recurrence and survival. METHODS: Charts from EC patients with FIGO Stage IIIc disease from 1989 to 1998 were abstracted for clinicopathologic data, pelvic (PLN) and para-aortic (PALN) nodal involvement, number of positive/removed nodes, and extranodal disease spread. Patterns of nodal distribution were evaluated for site of first recurrence and survival. Associations between variables were tested by chi(2) and Wilcoxon rank sums. Survival analyses were performed by the Kaplan-Meier method. RESULTS: Of 607 EC patients evaluated, 47 were identified with FIGO Stage IIIc disease. All 47 patients underwent hysterectomy and PLN sampling, and 42/47 had PALN sampling. The median number of PLN removed was 16 (range 2-35), and the median number of PALN was 7 (0-18). Stage IIIc disease was defined by positive PLN alone in 43%, positive PLN and PALN in 40%, and positive PALN alone in 17%. Positive peritoneal cytology and/or adnexal metastasis were present in 12 patients. Only 1/12 of these patients had isolated positive PLN whereas 11/12 had positive PALN (P = 0.007). An increasing number of positive PLN was associated with PALN metastasis (P = 0.0001), and of the 10 patients with bilateral PLN involvement, 9/10 also had positive PALN (P = 0.001). Sites of first recurrence were similar regardless of whether PALN were positive. At a median follow-up of 37 months, the 3-year survival estimate was 70% for patients with positive PALN versus 87% for those with isolated PLN disease (P = 0.22). For all patients neither the total number of positive PLN nor the total number of PLN or PALN removed was associated with survival. CONCLUSIONS: PALN involvement is common in patients with FIGO Stage IIIc endometrial cancer, suggesting that PLN sampling alone may result in underdiagnosis of disease. Patients with positive PALN had more extensive disease, but survival and patterns of failure were not significantly different from those with disease confined to PLN, suggesting that lymph node dissection may have a therapeutic role.

Adult↗
PubMed2001

Lead- and device-related complications in the antiarrhythmics versus implantable defibrillators trial.

BACKGROUND: Implantation of transvenous implantable cardioverter defibrillators (ICDs) by use of a nonthoracotomy approach has become routine therapy for survivors of life-threatening tachyarrhythmias. The purpose of this study was to identify and prospectively characterize the frequency of lead- and ICD-related complications from the Antiarrhythmics versus Implantable Defibrillators (AVID) Trial. METHODS AND RESULTS: Between June 1, 1993, and April 7, 1997, 539 patients received nonthoracotomy ICDs either as initial treatment assignment (477) or as crossover from medical management (62). A total of 62 first complications occurred. The subclavian route of insertion resulted in more complications than the cephalic vein route, 46 of 339 (14%) versus 6 of 135 (4%), P = .005, as did the abdominal versus pectoral generator site, 31 of 238 (13%) versus 17 of 291 (6%), P<.02. Most dislodgements and system infections tended to occur in the 3 months after implantation, whereas lead fractures continued to occur throughout follow-up. Failure to use perioperative antibiotics was a predictor of system infection (P = .001). CONCLUSIONS: These data suggest that cephalic vein access and pectoral generator site may result in fewer complications. The continued occurrence of lead fractures and the need for premature system revision supports the practice of close routine ICD system surveillance.

Anti-Arrhythmia Agents↗
PubMed2001

Multistage multiantigen heterologous prime boost vaccine for Plasmodium knowlesi malaria provides partial protection in rhesus macaques.

A nonhuman primate model for malaria vaccine development allowing reliable, stringent sporozoite challenge and evaluation of both cellular and antibody responses is needed. We therefore constructed a multicomponent, multistage DNA vaccine for the simian malaria species Plasmodium knowlesi including two preerythrocytic-stage antigens, the circumsporozoite protein (PkCSP) and sporozoite surface protein 2 (PkSSP2), and two blood stage antigens, apical merozoite antigen 1 (PkAMA1) and merozoite surface protein 1 (PkMSP1p42), as well as recombinant canarypox viruses encoding the four antigens (ALVAC-4). The DNA vaccine plasmids expressed the corresponding antigens in vitro and induced antiparasite antibodies in mice. Groups of four rhesus monkeys received three doses of a mixture of the four DNA vaccine plasmids and a plasmid encoding rhesus granulocyte-monocyte colony-stimulating factor, followed by boosting with a single dose of ALVAC-4. Three groups received the priming DNA doses by different routes, either by intramuscular needle injection, by intramuscular injection with a needleless injection device, the Biojector, or by a combination of intramuscular and intradermal routes by Biojector. Animals immunized by any route developed antibody responses against sporozoites and infected erythrocytes and against a recombinant PkCSP protein, as well as gamma interferon-secreting T-cell responses against peptides from PkCSP. Following challenge with 100 P. knowlesi sporozoites, 1 of 12 experimental monkeys was completely protected and the mean parasitemia in the remaining monkeys was significantly lower than that in 4 control monkeys. This model will be important in preclinical vaccine development.

Animals↗
PubMed2001

Calculating pass-through and outlier payments under APCs.

Medicare's outpatient prospective payment system is based on ambulatory payment classifications (APCs) that group services into categories for payment. The relative weight of each APC is based on the median operating and capital cost of the services within the group based on hospital outpatient claims data for 1996. These data, however, do not accurately reflect the cost of innovative medical devices, drugs, and biologicals currently in use. To account for these developments, the Balanced Budget Refinement Act of 1999 (BBRA) established the transitional pass-through payment system to provide additional amounts above the applicable APC rate for innovative medical devices, drugs, and biologicals. The BBRA also established a cost-outlier adjustment. Successfully calculating payments for pass-through and outlier devices requires that financial managers have a thorough knowledge of the medical devices, drugs, and biologicals being used in their outpatient surgery departments.

Ambulatory Care↗