Search

Residual dried blood spots from millions of newborns are being stored and used for research. The state of Michigan proactively developed a broad consent process for research use of newborns' blood spots. However, the extent to which mothers make informed choices about this research is unclear. A descriptive, qualitative study was conducted examining this issue. Twenty-nine observations of the consent process and 20 semistructured interviews were conducted with mothers on the postpartum unit of a large, academic hospital in Michigan. Content analysis of the transcripts was conducted. While most mothers agreed to donate the blood spots (n= 14/20; 70%), findings indicated that most decisions were uninformed (n= 16/20; 80%), as mothers lacked knowledge of biobanking research. Misunderstandings about anonymity, the consenter's credentials, and entity conducting the research seemed to influence decision making. Suggestions for improving the consent process include (1) changing the venue of blood spot education and consent from the postpartum period to the perinatal period, (2) strengthening the depth of information and delivery of information provided about the topic, including ethical and values clarification, and (3) increasing consenter education and training. Implementation may help increase the proportion of informed decisions. [ABSTRACT FROM AUTHOR]

Surveys provide evidence on practice, attitudes, and knowledge. However, conducting good survey research is harder than it looks. The authors aim to provide guidance to both researchers and readers in conducting and interpreting survey research. Like all research, surveys should have clear research question(s) using the smallest possible number of high-quality, essential, survey questions (items) that will interest the target population. Both researchers and readers should put themselves in the position of the respondents. The survey questions should provide reproducible results (reliable), measure what they are supposed to measure (valid), and take less than 10 min to answer. Good survey research reports provide results with valid and reliable answers to the research question with an adequate response rate (at least 40%) and adequate precision (margin of error ideally 5% or less). Possible biases among those who did not respond (nonresponders) must be carefully analyzed and discussed. Quantitative results can be combined with qualitative results in mixed-methods research to provide greater insight. [ABSTRACT FROM AUTHOR]

Background: Several studies suggest that many parents and research participants have poor understanding of the elements of consent, particularly the risks and benefits. However, some data suggest that the format and framing of research risks and benefits may be an important determinant of subject understanding. We examined the effect of tabular and graphical presentation of risks and benefits on parents' understanding of a research study., Methods: Parents of children scheduled to undergo an elective surgical procedure (n = 408) were randomized to receive information about the risks and benefits of a sham study of postoperative pain control using text, tables, or pictographs and then completed a questionnaire to examine their gist (essential) and verbatim (actual) understanding of the information. Parent demographics were recorded and their literacy and numeracy skills measured., Results: Parents randomized to receive information using tables or pictographs had significantly (P < 0.025) greater gist and verbatim understanding than did parents who received the information using standard text. Tables and pictographs were also superior to text in promoting understanding among parents with low numeracy and literacy skills., Conclusions: Many parents and patients have difficulty in assimilating and interpreting risk/benefit information for both research and treatment. This is due, in part, to the manner in which risks and benefits are communicated and to the literacy and numeracy abilities of the individual. The results of this study suggest a simple and practical method for enhancing understanding of risk/benefit statistics for parents with varying numeracy and literacy skills.

Background: Recent reports emphasize the risks associated with patient-controlled analgesia by proxy (PCA-P), yet data regarding such risks in children remain sparse. We compared the prevalence of clinically significant adverse events in children receiving PCA-P versus PCA, and examined factors that place children at increased risk., Methods: The records were reviewed of opioid-naïve children, ages birth to 18 yr, who received PCA or PCA-P after surgery. Data included demographics, comorbidities, perioperative information, pain, sedation, and respiratory assessments, oxygen saturation, analgesics, adverse outcomes, and interventions., Results: This study included 145 children who received PCA-P and 157 PCA. The PCA-P group was younger and had more comorbidities (P < 0.05). Opioid orders were similar, but pain scores and opioid dosages were lower, and fewer children received diazepam in the PCA-P group (P < 0.05). Clinically significant adverse events (i.e., those requiring intervention) occurred in 22% and 24% of patients in the PCA-P and PCA groups, respectively; however, more children in the PCA group had "threshold events" (minor intervention) and more in the PCA-P group had "rescue events" (opioid reversal or escalation of level of care). Respiratory events occurred earlier in the PCA-P group (P < 0.05). Factors associated with adverse events included orthopedic surgery, cognitive impairment, respiratory comorbidity, use of continuous basal opioid infusion, use of diazepam, and larger opioid doses on days 1, 2, and 3. Yet, cognitive impairment and opioid dose on day 1 were the only factors independently predictive of these events., Conclusions: This study found that although a significant number of children receiving PCA and PCA-P experienced adverse events, there was no difference in the prevalence between groups. The PCA-P group was at greater risk for events requiring rescue interventions, perhaps due to the prevalence of underlying comorbidities. These findings emphasize the need for vigilant monitoring to facilitate early recognition and timely intervention of respiratory depression.

Background: Consistent with the increasing prevalence of obesity in the United States and many countries worldwide, anesthesiologists are now presented with a greater number of adult and pediatric patients who are significantly overweight. This prospective study was designed to examine the relation between age-adjusted body mass index, preoperative comorbidities, and perioperative outcome in children., Methods: Children aged 2-18 yr undergoing noncardiac elective procedures were classified as overweight or obese based on their age- and sex-adjusted body mass index. Information was elicited regarding patient demographics, presence of comorbidities, and anesthetic technique. Data regarding the incidence and severity of perioperative adverse events were collected prospectively., Results: Two thousand twenty-five children comprised the sample (1,380 normal weight, 351 overweight, and 294 obese). Obese children had a significantly higher prevalence of comorbidities than nonobese children, including asthma, hypertension, sleep apnea, and type II diabetes. Furthermore, obese children had a higher incidence of difficult mask ventilation, airway obstruction, major oxygen desaturation (>10% of baseline), and overall critical respiratory adverse events. Logistic regression analysis revealed several risk factors for adverse events, including procedures involving the airway, obesity, age younger than 10 yr, and a history of obstructive sleep apnea., Conclusions: These results suggest that children presenting for elective surgical procedures who are obese have a greater prevalence of preexisting comorbid medical conditions and an increased incidence of perioperative adverse respiratory events compared with normal-weight children. Identification and awareness of risk factors for perioperative complications will be important in optimizing the anesthetic management of these children.

Background: Difficulty assessing pain has been cited as one of the primary reasons for infrequent and inadequate assessment and analgesia for children with cognitive impairment (CI). Several behavioral observational pain tools have been shown to have good psychometric properties for pain assessment in this population; however, routine clinical use may depend largely on their pragmatic qualities. We designed this study to evaluate pragmatic attributes or clinical utility properties of three recently developed pain assessment tools for children with CI., Methods: A sample of clinicians from three medical centers were asked to review 15 videotaped observations of children with CI, recorded during their first three postoperative days during participation in a previous study. Participants scored pain using the revised-Face, Legs, Activity, Cry, Consolability (r-FLACC) tool (individualized for the child during the previous study) for five observations, the noncommunicative Non-Communicating Children's Pain Checklist-Postoperative Version (NCCPC-PV) for five, and the Nursing Assessment of Pain Intensity (NAPI) for five observations. After their review of all segments, participants completed the Clinical Utility Attributes Questionnaire (CUAQ) ranking three attributes of clinical utility; complexity, compatibility, and relative advantage., Results: Five physicians and 15 nurses comprised the sample. There was excellent agreement between the coded pain scores (i.e., mild, moderate, severe pain) assigned using all tools and r-FLACC scores assigned by original observers (88%-98% exact agreement; kappa 0.71-0.96). The internal consistency or reliability of the CUAQ was supported by high alpha values for each of the subscales (alpha = 0.84-0.93). Subscale and total CUAQ scores were higher for the r-FLACC and NAPI compared with the NCCPC-PV. The r-FLACC had similar scores for complexity, but slightly higher scores for compatibility, relative advantage, and total utility compared with the NAPI., Conclusions: We found that clinicians rated the complexity, compatibility, relative advantage, and overall clinical utility higher for the r-FLACC and NAPI compared with the NCCPC-PV, suggesting that these tools may be more readily adopted into clinical practice.

Background: Research information for children is often presented in a manner that is difficult to understand. We designed this study, therefore, to examine the effect of improved readability and processability of written study information on children's understanding., Methods: One-hundred-ninety children aged 7-17 yr who were hospitalized for a surgical procedure or medical treatment were randomized to receive study information using either a standard form or a modified form with improved readability and processability. Children were interviewed to determine their understanding of eight study elements, including the risks, benefits, protocol, etc., and their responses scored by two independent assessors., Results: Children who were randomized to the modified form had significantly greater overall understanding of the information and greater understanding of the protocol and benefits (P < 0.05). The modified form was particularly effective in improving younger children's (7-10 yr) understanding of the material. Multivariate analysis identified several predictors of understanding, including the modified format, age, reading ability and the degree to which the child read the information. When shown both forms, 81.3% of children preferred the modified form stating that it was "friendlier" and "easier to read." The use of a larger font size and pictures were particularly popular., Conclusions: Results of this study suggest that modification of study information to better fit the ages and meet the reading and cognitive abilities of children results in their improved understanding and acceptance of the material.

Two recent studies have identified copious secretions as an independent risk factor for perioperative adverse events in children who present for elective surgery in the presence of an upper respiratory tract infection (URI). We designed this study, therefore, to determine whether the administration of the anticholinergic drug, glycopyrrolate, to children with URIs would reduce the incidence of adverse perioperative respiratory events. One hundred thirty children (1 mo to 18 yr of age) who presented for elective surgery with a URI were randomized to receive either 0.01 mg/kg glycopyrrolate or placebo and were followed for the appearance and severity of any perioperative respiratory adverse events. The two groups were similar with respect to demographics, presenting URI symptoms, anesthetic management, and surgical procedure. In the intention-to-treat analysis, there were no statistical differences in the incidence or severity of perioperative respiratory adverse events between the glycopyrrolate and placebo groups (45.2% vs 37.5% respectively, P = NS). Furthermore, there were no differences in outcome between the two groups when children with congestion and secretions were analyzed separately (45.0% vs 37.0%, respectively). However, compared with the placebo group, children in the glycopyrrolate group had significantly shorter discharge times (83.9 min vs 111.4 min, P = 0.024), and significantly less postoperative nausea and vomiting (10.7% vs 33.3%, P = 0.005). These results suggest that glycopyrrolate, administered after induction of anesthesia to children with URIs, does not reduce the incidence of perioperative respiratory adverse events, and thus may not be clinically indicated for routine use in this population.

Several observational and objective methods are available to assess sedation depth; however, data regarding their accuracy in differentiating deep sedation are limited. In this study we compared 3 sedation tools in children from birth to 18 yr of age and determined their relative value in detecting deep levels of sedation. Bispectral index monitoring (BIS), Modified Maintenance of Wakefulness Tests (MMWT), and the University of Michigan Sedation Scale (UMSS) were used to assess sedation. Three-hundred-twenty-seven observations were recorded in 39 children. The overall validity of each measure was supported by appropriate changes after sedation administration through the observation period. There were moderate to high correlations between UMSS and BIS (rho = -0.73) and UMSS and MMWT (rho = -0.59; P < 0.01). The correlation between BIS and MMWT was significant but low (r = 0.36; P < 0.01). Measures of exact agreement supported the reliability of the UMSS and MMWT across the sedation continuum. There were significant decreases in BIS across UMSS scores except from scores 2-3. ROC curves suggested that BIS < or = 80 and MMWT < or = 14 min were most sensitive in delineating deep sedation. Our findings demonstrate the overall validity of these observational and objective measures of sedation depth in children <18 yr of age but show ongoing limitations distinguishing moderate from deep sedation.

Purpose of Review: The decision to proceed with anesthesia for the child with an upper respiratory tract infection is often difficult. Whereas most studies suggest that children who present for elective procedures with an upper respiratory tract infection are at increased risk of perioperative adverse events, these events are typically easy to recognize and treat. This review will discuss the current literature regarding outcome in children who present for elective surgery with an upper respiratory tract infection and suggests approaches to optimize their perioperative management., Recent Findings: Although the literature regarding this important topic has been slow to evolve, recent large-scale outcome studies have identified a number of factors that increase the risk of perioperative adverse events among children with upper respiratory tract infections. The significance of these findings will be discussed., Summary: An understanding of the risk factors associated with administering anesthesia to the child with an upper respiratory tract infection is important in identifying elements of the preoperative assessment that merit attention and in optimizing the anesthetic plan as a means to limit any perioperative complications.

Acute lung injury after acid aspiration and increased ambient oxygen result in significant oxidative damage to the lungs. Lung antioxidant levels are also reduced. Because levels of serine proteinases in the airspaces are also dramatically increased, we hypothesized that these enzymes play a role in degrading lung antioxidants. Rats were treated with a serine proteinase inhibitor, aprotinin, before pulmonary aspiration of acid in the presence of increased ambient oxygen (hyperoxia). Lung Cu/Zn and Mn superoxide dismutase (SOD) activity (by colorimetric assay) and Cu/Zn SOD immune reactive protein (enzyme-linked immunosorbent assay) were assayed. The effects of antiproteinase treatment on acute lung injury were also assessed. Total SOD, Cu/Zn SOD, and Cu/Zn SOD antigenic protein levels were decreased in animals after acid aspiration and hyperoxia. However, Mn SOD activity was unchanged. The decrease in Cu/Zn SOD was attenuated in animals, where serine proteinase activity was inhibited. However, antiproteinase treatment did not decrease acute pulmonary injury, as assessed by leakage of radiolabeled albumin into the lung (permeability index), arterial blood gases, and markers of acute inflammation (pulmonary myeloperoxidase activity, a surrogate neutrophilic marker, and inflammatory cytokine profiles). We conclude that production of serine proteinases play a major role in degrading Cu/Zn SOD, thereby decreasing pulmonary antioxidant capacity. However, the role this plays in the pathogenesis of the acute lung injury is not clear.

One of the most controversial issues in pediatric anesthesia has revolved around the decision to proceed with anesthesia and surgery for the child who presents with an upper respiratory tract infection (URI). In the past, doctrine dictated that children with URIs have their surgery postponed until the child was symptom free. This practice was based on the empirically supported premise that anesthesia increased the risk of serious complications and complicated the child's postoperative course. Although recent clinical data confirm that some children with URIs are at increased risk of perioperative complications, these complications can, for the most part, be anticipated, recognized, and treated. Although the child with a URI still presents a challenge, anesthesiologists are now in a better position to make informed decisions regarding the assessment and management of these children, such that blanket cancellation has now become a thing of the past.

Between February, 2000 and August, 2002 three surveys have been submitted to the program directors of the anesthesiology training programs in the United States (U.S.) to assess the departments' needs for faculty and financial support from their institutions. In this article we present the results of a fourth follow-up survey. This survey also asked questions regarding the need for additional support to meet the new 80-h workweek resident requirement and asked the average academic time offered to faculty. The average department has 40 faculty members with 3.7 open faculty positions in the 78% of departments with open positions. Only 25% of the departments planned to add personnel to comply with the 80-h resident workweek. Fifty-one percent of the departments had a positive financial margin of 15,908 dollars/full-time equivalent (FTE) faculty anesthesiologist (faculty FTE), whereas 34% had a negative margin of 42,603 dollars/faculty FTE. The overall institutional support was 85,607 dollars/faculty FTE, which is a 43% increase over the previous year. The average academic time provided to faculty was 13.8%, a decline from 20% in 2000. Twenty-five percent of departments have closed an anesthetizing location as a result of a lack of faculty in 2003. Open faculty positions in U.S. training programs have remained fairly constant at 8% to 10% from 2000 to 2003. Institutional support for training departments has more than doubled since 2000, reaching approximately 85,000 dollars/faculty in 2003.

Background: Interindividual variability of platelet inhibition after aspirin or clopidogrel administration has been described. Additionally, aspirin resistance and clopidogrel resistance occur in some individuals. Because the prodrug clopidogrel is activated by hepatic cytochrome P450 (CYP) 3A4, we hypothesized that interindividual variability in clopidogrel efficacy might be related to interindividual differences in CYP3A4 metabolic activity., Methods and Results: Platelet aggregation was measured before and after clopidogrel treatment in 32 patients undergoing coronary artery stent implantation and in 35 healthy volunteers. The erythromycin breath test was used to measure CYP3A4 activity in vivo in 25 of the healthy volunteers. Individual platelet aggregation was studied in 10 healthy volunteers after the coadministration of clopidogrel and rifampin (a CYP3A4 inducer). Clopidogrel nonresponders, low responders, and responders were defined by a relative inhibition of adenosine diphosphate (20 micromol/L)-induced platelet aggregation of <10%, 10% to 29%, and > or =30%, respectively. Among patients, 22% were clopidogrel nonresponders, 32% were low responders, and 47% were responders. Among volunteers, 16% were nonresponders, 12% were low responders, and 72% were responders. Percent platelet aggregation after clopidogrel inversely correlated with CYP3A4 activity (r=-0.6, P=0.003). Improved platelet inhibition in volunteers resistant to clopidogrel was observed with the coadministration of clopidogrel and rifampin., Conclusions: Clopidogrel administration results in interindividual variability in platelet inhibition, which correlates with CYP3A4 metabolic activity. Measurement of antiplatelet drug efficacy with a point-of-care device and alternative antithrombotic strategies for aspirin or clopidogrel nonresponders and low responders could reduce the incidence of thrombotic events that continue to occur despite oral antiplatelet therapy.