PubMed Health⌕ Search

Biomedical subjects

S Joffe

Publications and source records attributed to S Joffe.

At least 19 recordsLinked to original sources
PubMed2003

What do patients value in their hospital care? An empirical perspective on autonomy centred bioethics.

OBJECTIVE: Contemporary ethical accounts of the patient-provider relationship emphasise respect for patient autonomy and shared decision making. We sought to examine the relative influence of involvement in decisions, confidence and trust in providers, and treatment with respect and dignity on patients' evaluations of their hospital care. DESIGN: Cross-sectional survey. SETTING: Fifty one hospitals in Massachusetts. PARTICIPANTS: Stratified random sample of adults (N=27 414) discharged from a medical, surgical, or maternity hospitalisation between January and March, 1998. Twelve thousand six hundred and eighty survey recipients responded. MAIN OUTCOME MEASURE: Respondent would definitely be willing to recommend the hospital to family and friends. RESULTS: In a logistic regression analysis, treatment with respect and dignity (odds ratio (OR) 3.4, 99% confidence interval (CI) 2.8 to 4.2) and confidence and trust in providers (OR 2.5, CI 2.1 to 3.0) were more strongly associated with willingness to recommend than having enough involvement in decisions (OR 1.4, CI 1.1 to 1.6). Courtesy and availability of staff (OR 2.5, CI 2.1 to 3.1), continuity and transition (OR 1.9, CI 1.5 to 2.2), attention to physical comfort (OR 1.8, CI 1.5 to 2.2), and coordination of care (OR 1.5, CI 1.3 to 1.8) were also significantly associated with willingness to recommend. CONCLUSIONS: Confidence and trust in providers and treatment with respect and dignity are more closely associated with patients' overall evaluations of their hospitals than adequate involvement in decisions. These findings challenge a narrow emphasis on patient autonomy and shared decision making, while arguing for increased attention to trust and respect in ethical models of health care.

Adolescent↗
PubMed2001

Quality of informed consent in cancer clinical trials: a cross-sectional survey.

BACKGROUND: Investigators have to obtain informed consent before enrolling participants in clinical trials. We wanted to measure the quality of understanding among participants in clinical trials of cancer therapies, to identify correlates of increased understanding, and to assess providers' beliefs about clinical research. We also sought evidence of therapeutic misconceptions in participants and providers. METHODS: We sent a standard questionnaire to 287 adult patients with cancer who had recently enrolled in a clinical trial at one of three affiliated institutions, and surveyed the provider who obtained each patient's consent. FINDINGS: 207 of 287 (72%) patients responded. 90% (186) of these respondents were satisfied with the informed consent process and most considered themselves to be well informed. Nevertheless, many did not recognise non-standard treatment (74%), the potential for incremental risk from participation (63%), the unproven nature of the treatment (70%), the uncertainty of benefits to self (29%), or that trials are done mainly to benefit future patients (25%). In multivariate analysis, increased knowledge was associated with college education, speaking only English at home, use of the US National Cancer Institute consent form template, not signing the consent form at initial discussion, presence of a nurse, and careful reading of the consent form. Only 28 of 61 providers (46%) recognised that the main reason for clinical trials is benefit to future patients. INTERPRETATION: Misconceptions about cancer clinical trials are frequent among trial participants, and physician/investigators might share some of these misconceptions. Efforts to educate providers and participants about the underlying goals of clinical trials are needed.

Adult↗
PubMed2001

Quality of informed consent: a new measure of understanding among research subjects.

BACKGROUND: The informed consent of participants is ethically and legally required for most research involving human subjects. However, standardized methods for assessing the adequacy of informed consent to research are lacking. METHODS AND RESULTS: We designed a brief questionnaire, the Quality of Informed Consent (QuIC), to measure subjects' actual (objective) and perceived (subjective) understanding of cancer clinical trials. The QuIC incorporates the basic elements of informed consent specified in federal regulations, assesses the therapeutic misconception (the belief that all aspects of a clinical trial are designed to directly benefit the subject), and employs the language and structure of the new National Cancer Institute template for informed consent documents. We modified the QuIC after receiving feedback from pilot tests with cancer research subjects, as well as validation from two independent expert panels. We then sent the QuIC to 287 adult cancer patients enrolled on phase I, II, or III clinical trials. Two hundred seven subjects (72%) completed the QuIC. To assess test-retest reliability, a random sample of 32 respondents was selected, of whom 17 (53%) completed the questionnaire a second time. The test-retest reliability was good with intraclass correlation coefficients of.66 for tests of objective understanding and.77 for tests of subjective understanding. The current version of the QuIC, which consists of 20 questions for objective understanding and 14 questions for subjective understanding, was tested for time and ease of administration in a sample of nine adult cancer patients. The QuIC required an average of 7.2 minutes to complete. CONCLUSIONS: The QuIC is a brief, reliable, and valid questionnaire that holds promise as a standardized way to assess the outcome of the informed consent process in cancer clinical trials.

Adult↗
PubMed2001

Inflammatory bowel disease associated with immune thrombocytopenic purpura in children.

OBJECTIVE: Previous reports suggest an association between inflammatory bowel disease (IBD) and immune thrombocytopenic purpura (ITP) in adults. To date, only five children with both diseases have been described. The aim of the study was to describe the characteristics of children with IBD and ITP. METHODS: Cases were obtained from the pediatric gastroenterology community by means of the pediatric gastroenterology internet bulletin board in June 1999. Eight cases were submitted from seven medical centers. Medical records were reviewed by two pediatric gastroenterologists and a pediatric hematologist. RESULTS: The age range of the patients was 2.1 to 16.5 years, with a mean age of 9.6 +/- 5.2 years. Four children had ulcerative colitis, three had Crohn disease, and one had indeterminate colitis. All had colonic involvement of IBD. Of eight patients, three had IBD first, three had ITP first, and two had both simultaneously. At ITP diagnosis, platelet count was less than 10,000/mL in five children, 17,000/mL in one child, and 50,000 to 60,000/mL in two children. Of the three children diagnosed with ITP first, two initially had rectal bleeding at the time of ITP diagnosis. Bone marrow evaluations, performed in six of eight children, were consistent with ITP. Six of the eight children had chronic ITP, including three children who were 5 years of age or younger. Therapy for ITP included steroids (n = 6), intravenous immunoglobulin (n = 6), Rh o (D) intravenous immunoglobulin (n = 2), and splenectomy (n = 1). CONCLUSIONS: The authors describe the largest pediatric case series of children with IBD and ITP. More than 50% of the children had the chronic form of ITP. Most patients responded to conventional therapy for ITP and IBD.

Adolescent↗
PubMed1999

Rehospitalization in the first two weeks after discharge from the neonatal intensive care unit.

BACKGROUND: High-risk newborns are known to have higher than average utilization of services after discharge from the neonatal intensive care unit (NICU). Most studies on this subject report aggregate data over periods ranging from 1 to 3 years postdischarge. Little is known about events that are temporally close to NICU discharge. OBJECTIVES: To characterize rehospitalizations within the first 2 weeks after discharge from six community NICUs. METHODS: We scanned electronic databases and reviewed the charts of rehospitalized infants from six NICUs in the Kaiser Permanente Medical Care Program. We subdivided infants into five groups based on gestational age (GA) and birth hospitalization length of stay (LOS): 1) >/=37 weeks' GA with <4 days LOS (n = 2593); 2) >/=37 weeks' GA with >/=4 days' LOS (n = 1133); 3) from 33 to 36 weeks' GA with <4 days' LOS (n = 545); 4) from 33 to 36 weeks' GA with >/=4 days' LOS (n = 1196); and 5) <33 weeks' GA (n = 587). We performed bivariate and multivariate analyses to identify predictors that might be useful for practitioners. RESULTS: There were 6054 newborns discharged alive from the six study NICUs between August 1, 1992 and December 31, 1995, and 99.5% of these infants remained in the health plan during the 2 weeks after NICU discharge. The overall rehospitalization rate was 2.72%, which is 20% higher than the rate among healthy term newborns in the Kaiser Permanente Medical Care Program (2.26%). The two most common reasons for rehospitalization were jaundice (62/165, 37.6%) and feeding difficulties (25/165, 15.2%). Infants with 33 to 36 weeks' GA and <4 days' LOS were rehospitalized at a significantly higher rate than were all other infants (5.69%); 71% of infants in this group were rehospitalized for jaundice. The following variables predicted rehospitalization in multivariate models: <33 weeks' GA (adjusted OR [AOR]: 1.88; 95% CI: 1.10-3.21), from 33 to 36 weeks' GA with <96 hours' LOS (AOR: 2.94; 95% CI: 1.87-4.62), and birth at facility B, which had the highest rehospitalization rate of the six facilities (AOR: 1.92; 95% CI: 1.39-2.65). CONCLUSIONS: The rate of rehospitalization among NICU graduates is higher than among healthy term infants. Most of the rehospitalizations among infants with from 33 to 36 weeks' GA and <4 days' LOS are for illnesses that are not life-threatening. Collaborative studies and new process and outcomes measures are needed to assess the effectiveness of follow-up strategies in high-risk newborns.

Birth Weight↗
PubMed1999

Cost-effectiveness of respiratory syncytial virus prophylaxis among preterm infants.

OBJECTIVES: To evaluate the costs and benefits of two new agents, respiratory syncytial virus immune globulin (RSVIG) and palivizumab, to prevent respiratory syncytial virus (RSV) infection among premature infants discharged from the neonatal intensive care unit (NICU) before the start of the RSV season. Method. Decision analysis was used to compare the projected societal cost-effectiveness of three strategies-RSVIG, palivizumab, and no prophylaxis-among a hypothetical cohort of premature infants. Probabilities and costs of hospitalization were derived from a cohort of 1721 premature infants discharged from six Kaiser Permanente-Northern California NICUs. Efficacies of prophylaxis were based on published trials. Costs of prophylaxis were derived from published sources. Mortality among infants hospitalized for RSV was assumed to be 1.2%. Future benefits were discounted at 3%. RESULTS: Palivizumab was both more effective and less costly than RSVIG. Cost-effectiveness varied widely by subgroup. Palivizumab appeared most cost-effective for infants whose gestational age was </=32 weeks, who required >/=28 days of oxygen in the NICU, and who were discharged from the NICU from September through November. In this subgroup, palivizumab was predicted to cost $12,000 per hospitalization averted (after taking into account savings from prevention of RSV admissions) or $33,000 per life-year saved, and the number needed to treat to avoid one hospitalization was estimated at 7.4. However, for all other subgroups, ratios ranged from $39,000 to $420,000 per hospitalization averted or $110,000 to $1,200,000 per life-year saved, and the number needed to treat extended from 15 to 152. The results were sensitive to varying assumptions about the cost and efficacy of prophylaxis, as well as the probability of hospitalization, but were less sensitive to the cost of hospitalization. CONCLUSION: In our model, the cost of prophylaxis against RSV for most subgroups of preterm infants was high relative to the benefits realized. Lower costs might permit the benefits of prophylaxis to be extended to additional groups of preterm infants.

Antibodies, Monoclonal↗
PubMed1999

Rehospitalization for respiratory syncytial virus among premature infants.

OBJECTIVES: New interventions to prevent respiratory syncytial virus (RSV) have recently become available. Clinical decisions about the use of these interventions require a better understanding of the incidence of and risk factors for RSV. We sought to characterize the epidemiology of severe RSV disease among premature infants and to identify high-risk subgroups. DESIGN: Retrospective cohort. SETTING: Kaiser Permanente Northern California, July 1992 to April 1996. PARTICIPANTS: One thousand seven hundred twenty-one premature infants born at 23 to 36 weeks who were discharged from a neonatal intensive care nursery (NICU) within 12 months before the December to March RSV season. A secondary analysis included 769 infants discharged during the RSV season. OUTCOME MEASURES: Hospitalization for RSV. RESULTS: Of 1721 infants already home from the NICU at the start of the season, 3.2% were rehospitalized for RSV. In a multivariate model, risk factors for RSV hospitalization included gestation </=32 weeks (odds ratio [OR], 2.6), >/=28 days of perinatal oxygen (OR, 3.7), and NICU discharge during September to November (OR, 2.7). Predicted risk of hospitalization varied by subgroup, ranging from 1.2% to 24.6%. Among 769 infants discharged from the NICU during the RSV season, 3.5% were rehospitalized for RSV during the same season; gestation and perinatal oxygen were not associated with admission. CONCLUSIONS: Most premature infants in this population were at less risk of severe RSV disease than previous studies in other populations have suggested. Preterm infants with a lower gestational age, a prolonged perinatal oxygen requirement, and NICU discharge within 3 months of the RSV season were most likely to require hospitalization for RSV disease. Cost-effectiveness analyses are needed to help define the role of available prophylactic interventions.

California↗
PubMed1988

Physiological insulin action is opposed by beta-adrenergic mechanisms in dogs.

To investigate the possible role of adrenergic mechanisms in modulating glucose homeostasis during physiological insulin changes, we studied the effects of alpha-, beta-, or combined alpha- and beta-adrenergic blockade on glucose production (Ra) and utilization (Rd) via isotope ([3-(3)H]glucose) dilution during nonstressful, nonhypoglycemic conditions in response to physiological insulin changes in conscious dogs. Without adrenergic blockade, infusion of insulin at 0.275 mU.kg-1.min-1 (control) caused glucose to fall from 92 +/- 4 to 82 +/- 4 mg/dl over 30 min, because of transient fall in Ra from 2.8 +/- 0.4 to 2.3 +/- 0.3 mg.kg-1.min-1, which recovered to base line by 30 min. There was a later rise in Rd to 3.9 +/- 0.4 mg.kg-1.min-1 at 45 min, but no counter-regulatory hormonal changes (glucagon, cortisol, epinephrine, and norepinephrine) to account for these findings in glucose kinetics. alpha-Blockade alone led to an initial rise in base-line insulin and consequent fall in glucose, associated with a transient fall in Ra but no change in Rd; infusion of insulin led to a further small fall in glucose, with no change in Ra, but with a rise at 30 min in Rd similar to controls. beta-Blockade alone led to an initial fall in insulin and modest rise in glucose; insulin infusion led to a greater rate of fall in glucose than in controls (from 112 +/- 6 to 78 +/- 7 mg/dl over 30 min).(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic alpha-Antagonists↗
PubMed1987

Effects of electrocautery, CO2 laser, and contact Nd:YAG laser scalpel on the healing of intestinal incision.

Leakage after intestinal resection is a serious complication with a high mortality rate. A recent study claims that cutting the intestine with the CO2 laser improves the healing of intestinal anastomoses (Ferulano et al: Eur Surg Res 16:127-130, 1984). The present study was undertaken to analyze the effects of electrocautery, CO2 laser, and contact Nd:YAG laser on the healing of intestinal incisions. Fifteen piglets were used and the cutting and reanastomosing were performed by using all cutting methods in each animal in randomized order. Resection sites were 50 cm, 100 cm, and 150 cm distal to the ligament of Treitz. On the seventh day the bursting pressures were measured for each anastomosis. They were 172 +/- 17 mmHg for normal bowel segment and 133 +/- 12, 135 +/- 40, and 139 +/- 17 mmHg for electrocautery, CO2 laser, and Nd:YAG laser, respectively. There were no mortality, no anastomotic leaks, and no statistically significant differences in the bursting pressures, in histology, or in the healing of anastomotic sites, indicating that electrocautery, CO2 laser, and contact Nd:YAG laser scalpel can safely be used in the surgery of small intestine.

Animals↗
PubMed1987

The regulation of basal pancreatic polypeptide levels in dogs.

In response to various stimuli, pancreatic polypeptide (PP) release is predominantly mediated by cholinergic mechanisms, and may be modulated by sympathetic and opiate (inhibitory) effects. However, the mechanisms regulating basal PP levels remain unclear. We examined the possible role of the sympathetic nervous system and endogenous opiates in the regulation of basal levels of pancreatic polypeptide in trained conscious dogs. During prolonged (150 min) alpha- or beta-adrenergic blockade with phentolamine and propranolol, separately or in combination, there was no change in the basal PP levels of 154 +/- 20 pg/ml. Effective adrenergic modulation of pancreatic hormones was evident since alpha blockade led to a rise in insulin and glucagon, beta blockade led to a fall in insulin and glucagon, while combined alpha- and beta-adrenergic blockade did not affect insulin or glucagon. Opiate blockade with naloxone (1.25 mg followed by 1 microgram/kg/min) led to a delayed fall in PP from 153 +/- 22 to 89 +/- 15 pg/ml at 90 min (no change by 30 min), without a change of insulin or glucagon. Infusion of a potent morphine analogue D-Met2-Pro5-enkephalinamide (0.5 microgram/kg/min) led to a sustained fall in PP to 91 +/- 8 pg/ml by 30 min without a change in insulin or glucagon. Somatostatin infusion (0.2 microgram/kg/min) with insulin and glucagon replacement, led to a similar sustained fall in PP. It is concluded that in dogs: in contrast to insulin and glucagon, at basal conditions the plasma level of PP is not modulated by endogenous alpha- or beta-adrenergic influences.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1985

Opiate modulation of glucose turnover in dogs.

We examined the effect of opiate infusion and of opiate blockage on glucose turnover in the basal state, using isotope dilution techniques in trained conscious dogs (n = 5). After a primed-continuous infusion of 3-3H glucose to steady state specific activity (90 minutes), infusion of one of the following was given: D-met2 pro5 enkephalinamide (DMPE), a potent morphine-like opiate, 0.5 mus g/kg/min; naloxone, an opiate antagonist, 1.25 mg followed by 10 mus g/min; or saline control. Infusion of DMPE led to a fall in glucose from 92 +/- 3 to 87 +/- 3 mg/dL by 60 minutes (P less than 0.05), associated with a rise in glucose utilization (Rd) from 3.0 +/- 0.4 to 3.9 +/- 0.6 mg/kg/min by 30 minutes (P less than 0.05); a transient rise in glucose production (Ra; from 3.2 +/- 0.4 to 4.3 +/- 0.4 mg/kg/min; P less than 0.05). Changes in counterregulatory hormones did not account for these findings; insulin was unchanged during all infusions; glucagon showed small late rises at 75 minutes during both DMPE and naloxone infusion; cortisol rose by 30 and 15 minutes, respectively, of DMPE and naloxone infusion; epinephrine rose transiently after 5 minutes of naloxone but was unchanged during DMPE, and norepinephrine was unchanged throughout. Saline infusion had no effects on any of these indices. We conclude that a potent opiate with morphine-like effects (DMPE) can lower glucose in dogs by enhancing peripheral glucose utilization independently of hormonal changes.

Animals↗
PubMed1985

Recombination and deletion of sequences in shuttle vector plasmids in mammalian cells.

Shuttle vector plasmids were constructed with directly repeated sequences flanking a marker gene. African green monkey kidney (AGMK) cells were infected with the constructions, and after a period of replication, the progeny plasmids were recovered and introduced into bacteria. Those colonies with plasmids that had lost the marker gene were identified, and the individual plasmids were purified and characterized by restriction enzyme digestion. Recombination between the repeated elements generated a plasmid with a precise deletion and a characteristic restriction pattern, which distinguished the recombined molecules from those with other defects in the marker gene. Recombination among the following different sequences was measured in this assay: (i) the simian virus 40 origin and enhancer region, (ii) the AGMK Alu sequence, and (iii) a sequence from plasmid pBR322. Similar frequencies of recombination among these sequences were found. Recombination occurred more frequently in Cos1 cells than in CV1 cells. In these experiments, the plasmid population with defective marker genes consisted of the recombined molecules and of the spontaneous deletion-insertion mutants described earlier. The frequency of the latter class was unaffected by the presence of the option for recombination represented by the direct repeats. Both recombination and deletion-insertion mutagenesis were stimulated by double-strand cleavage between the repeated sequences and adjacent to the marker, and the frequency of the deletion-insertion mutants in this experiment was again independent of the presence of the direct repeats. We concluded that although recombination and deletion-insertion mutagenesis were both stimulated by double-strand cleavage, the molecules which underwent the two types of change were drawn from separate pools.

Animals↗
PubMed1984

Opiates modulate insulin action in vivo in dogs.

To investigate the influence of opiates on insulin action in vivo, we induced mild physiological hyperinsulinaemia (15-20 mU/l) in five trained conscious dogs in the absence or presence of ongoing infusion with the opiate agonist D-met2-pro5-enkephalinamide (DMPE, 0.5 micrograms X kg-1 X min-1), or the opiate antagonist naloxone (1.25 mg followed by 1 microgram X kg-1 X min-1). The effects on glucose production and glucose utilization were measured by isotope dilution using 3-3H-glucose. Glucose fell similarly over 30 min in response to insulin in controls (0.021 +/- 0.003 mmol X l-1 X min-1), and both the DMPE and naloxone studies (0.016 +/- 0.002 mmol X l-1 X min-1 and 0.017 +/- 0.003 mmol X l-1 X min-1, respectively). In control dogs, insulin lowered glucose by transiently suppressing production by 0.028 +/- 0.006 mmol X kg-1 X min-1 at 20-30 min without changing utilization. In contrast, in both the DMPE and naloxone studies insulin lowered glucose by markedly raising utilization at 20 min by 0.094 +/- 0.017 and 0.139 +/- 0.022 mmol X kg-1 X min-1, respectively. Furthermore, insulin failed to suppress production in both DMPE and naloxone studies and, as plasma glucose fell, production rose in both treatment groups at 20 min by 0.045 +/- 0.012 and 0.089 +/- 0.022 mmol X kg-1 X min-1 respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1976

Drug prevention of postoperative deep vein thrombosis. A compararative study of calcium heparinate and sodium pentosan polysulfate.

Deep vein thrombosis and its sequel, pulmonary embolus, are possibly the greatest threats to recovery after surgical operation. In a randomized, controlled clinical trial in which the 125I-fibrinogen uptake test, Doppler ultrasound, and phlebography were used for diagnosis, it was found that low doses of calcium heparinate administered subcutaneously and sodium pentosan polysulfate intramuscularly were effective in preventing deep vein thrombosis (DVT), postoperatively. The incidence of DVT was as follows: 9% in the group treated with heparinate; 15% in the group treated with sodium pentosan polysulfate; nad 51% in the untreated control group.

Adult↗