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Biomedical subjects

J D Powers

Publications and source records attributed to J D Powers.

At least 19 recordsLinked to original sources

Predictors of a child's ability to use a visual analogue scale.

BACKGROUND: Visual analogue scales (VAS) are used to assess the strength of perceptions of both children and adults in many clinical and research settings. Although the VAS has been shown by some authors to be reliable for use by children aged 5 years and older, others have proposed that young children, generally < or =7 years of age, may not have the conceptual ability to use a VAS. OBJECTIVE: To identify demographic and cognitive variables that would maximize the accuracy of predicting children's abilities to use a VAS. METHODS: Forty kindergarten children performed a seriation task, used a VAS to perform a calibration task and completed the Block Design and Vocabulary subtests of the Wechsler Preschool and Primary Scale of Intelligence-Revised (WPPSI-R). An estimated IQ was calculated from the WPPSI-R subtest scores. Socioeconomic status was assessed using the Hollingshead Four Factor Index of Social Status. Logistic regression was used to determine the best predictive models. Sensitivity, specificity, negative predictive value, positive predictive value and accuracy were calculated for statistically significant predictive models. MAIN OUTCOME MEASURE: Successful completion of the calibration study by the child. RESULTS: Only 42% of the subjects could use a VAS. The subject's age (> or =5.6 years), combined with estimated IQ (> or =100), was the best predictor of a child's ability to use a VAS (88% accuracy). CONCLUSION: The majority of kindergarten children in our study could not complete a VAS accurately. Cognitive ability, combined with chronological age, was the best predictor of a child's accurate use of a VAS, as determined by logistic regression. Paediatric researchers may need to consider alternative rating scales to measure perceptions in children under 7 years of age.

Aptitude↗

Statistical comparison of dissolution curves.

The purpose of this investigation was to develop statistical procedures to determine if two sets of dissolution curves could have come from the same population of curves. The f(2)statistic developed by the Food and Drug Administration, FDA, has been shown to have many limitations and is too liberal in concluding similarity between dissolution profiles. The procedure currently used by the FDA involves computing the mean amount dissolved at each time and then comparing the two mean curves. This approach ignores all of the variability within sets of profiles, which, from a statistical viewpoint, is a serious limitation. This investigation presents three different statistics for comparison of dissolution curves with associated decision rules and power functions. These three statistics are extensions of existing procedures: (1) an extension of the Mann--Whitney test which compares the variability within each set of profiles and between the two sets; (2) an extension of the Kolmogorov--Smirnov D statistic which compares three empirical cumulative distribution functions; and (3) an adaptation of the well known chi-squared test. A computer program, which includes the algorithm for each of the three statistics and varying sample sizes, is also available.

Algorithms↗

On the determination of bioequivalence.

The characteristics and advantages of a new method for the determination of bioequivalence are described. This method does not employ AUC or Cmax, therefore it does not depend on a number of assumptions usually needed for the validity of the traditional method.

Absorption↗

Prilocaine-phenylephrine and bupivacaine-phenylephrine topical anesthetics compared with tetracaine-adrenaline-cocaine during repair of lacerations.

The effectiveness of two new topical anesthetics that do not contain cocaine (prilocaine-phenylephrine and bupivacaine-phenylephrine) was compared with that of tetracaine-adrenaline-cocaine (TAC) during laceration repair in children. This study was a prospective, randomized, double-blind trial conducted in the emergency department of a large children's hospital. Participants were 180 children 1 year of age or older with a laceration 5 cm or less in length that required suturing. Pain felt during suturing was scored by suture technicians, research assistants, parents, and patients 5 years of age and older using a visual analogue scale (VAS). There was no statistical difference demonstrated between the effectiveness of prilocaine-phenylephrine and that of TAC for any of the observer groups. A statistically significant difference was seen among anesthetics when comparing VAS scores of research assistants (P = .002), suture technicians (P = .006), and parents (P = .03), but not when comparing VAS ratings of patients (P = .07). Based on Tukey's post hoc test, these statistically significant differences were between TAC and bupivacaine-phenylephrine. When power analyses were performed using alpha = 0.05 and beta = 0.20, it was possible to detect a difference of 1.3 VAS units for each rater group. In conclusion, this study demonstrated the effectiveness and safety of prilocaine-phenylephrine and bupivacaine-phenylephrine. Prilocaine-phenylephrine statistically outperformed bupivacaine-phenylephrine and offers an effective alternative to TAC during laceration repair in children.

Adolescent↗

Tetracaine-lidocaine-phenylephrine topical anesthesia compared with lidocaine infiltration during repair of mucous membrane lacerations in children.

This study compared the effectiveness of a new topical anesthetic, tetracaine-lidocaine-phenylephrine (TetraLidoPhen), with that of lidocaine infiltration during repair of mucous membrane lacerations in children. It was conducted in the emergency department of an urban children's hospital with use of a prospective, randomized, blinded study design. Participants were 90 children 1 year of age or older with a laceration 5 cm or less in length on or near a mucous membrane that required suturing. They were randomly assigned to one of two treatment groups, with 45 patients in each group. Pain felt during suturing was scored by suture technicians, research assistants, a videotape reviewer, parents, and patients 5 years of age and older using a Visual Analogue Scale (VAS). Suture technicians, research assistants, a videotape reviewer, and parents also scored pain using a seven-point Likert scale. In addition, suture technicians completed an Anesthesia Effectiveness scale and a Wound Blanching scale. The laceration was located near the eyes in 71 patients (79%), and on or near the lips in 19 (21%). Lidocaine infiltration performed significantly better than topical TetraLidoPhen in comparisons of Likert scores of suture technicians (P = 0.007), research assistants (P = 0.005), the videotape reviewer (P = 0.003), and parents (P = 0.03); Anesthetic Effectiveness scale scores of suture technicians (P = 0.00002; relative risk (RR) = 1.83, 95% confidence interval 1.36 < RR < 2.46); and VAS scores of suture technicians (P = 0.002), research assistants (P = 0.001), and the videotape reviewer (P = 0.005). No significant difference in performance was detected between lidocaine and TetraLidoPhen in comparing VAS scores of parents and patients. There was a 4.4% wound complication rate, including two (2.2%) wound infections. The authors conclude that TetraLidoPhen is a new topical anesthetic that appears to be safe when applied on or near mucous membranes. Its performance among study participants was statistically inferior to that of lidocaine infiltration; however, the differences in pain scores were small and may not be clinically significant. Also, comparisons of pain scores in this study did not take into account the pain associated with the initial injection of lidocaine. Therefore, study findings may underestimate the comparative performance of TetraLidoPhen. Further investigation of this new topical anesthetic is warranted.

Anesthesia, Local↗

Prilocaine-phenylephrine topical anesthesia for repair of mucous membrane lacerations.

OBJECTIVE: To compare the effectiveness of prilocaine-phenylephrine (Prilophen), a new topical anesthetic that does not contain cocaine, to that of lidocaine infiltration during repair of lacerations on or near mucous membranes in children. DESIGN: A prospective, randomized, blinded trial. SETTING: The emergency department of a large academic children's hospital. PATIENTS: Children one year of age or older with a laceration 5 cm or less in length on or near a mucous membrane. INTERVENTIONS: Forty patients were randomly assigned one of the two local anesthetics, with 20 patients in each treatment group. OUTCOME MEASURES: Pain felt during suturing was scored by suture technicians, research assistants, a videotape reviewer, parents, and patients five years of age and older using a visual analog scale (VAS). RESULTS: There was no statistically significant difference in performance between topical Prilophen and lidocaine infiltration when VAS pain scores of research assistants, parents, and patients were compared. However, lidocaine infiltration performed significantly better than topical Prilophen when comparing VAS scores of suture technicians (P = 0.003) and the videotape reviewer (P = 0.02). When power analyses were performed using alpha = 0.05 and beta = 0.20, it was possible to detect a difference of 2 units for VAS scores of suture technicians, 2 VAS units for research assistants, 3 VAS units for the videotape reviewer and parents, and 7 VAS units for patients. There were no wound healing or other complications. CONCLUSIONS: Prilophen is a new topical anesthetic alternative to lidocaine infiltration for closure of lacerations on or near mucous membranes, where use of tetracaine-adrenaline-cocaine is contraindicated. The performance of Prilophen was rated by two of the observer groups as statistically inferior to that of lidocaine infiltration; however, the differences in pain scores were small and may not be clinically significant. Further investigation of this new topical anesthetic is warranted.

Adolescent↗

Comparison of topical anesthetics with lidocaine infiltration during laceration repair in children.

This study is a randomized, blinded trial that compares the effectiveness of a new topical anesthetic preparation of 2% mepivacaine and 1:100,000 norepinephrine (Mepivanor); a topical solution of 1% tetracaine, 1:4,000 adrenaline, and 4% cocaine (TAC); and 1% lidocaine infiltration during laceration repair in children. The study was conducted in the emergency department of a large academic children's hospital. Study participants were children 2 years of age or older with a laceration on the face or scalp, 5 cm or less in length, that required suturing. Patients were randomly assigned to receive Mepivanor topical solution, TAC topical solution, or lidocaine infiltration anesthesia prior to laceration repair. Seventy-one patients were enrolled in the study during a 2-month period. Outcome measures assessed pain perceptions using a Visual Analogue Scale (VAS) and a seven-point Likert scale. There was statistical power to detect differences of 1.2 to 1.7 units for the VAS outcome measures using alpha = 0.05 and beta = 0.20. There were no statistically significant (P > 0.05) differences between TAC and 1% lidocaine infiltration in providing effective anesthesia. Mepivanor was generally less effective in providing adequate anesthesia during laceration repair than TAC and lidocaine infiltration, with Tukey's post hoc test for ANOVA demonstrating statistically significant (P < 0.05) differences between Mepivanor and these agents for research assistant and suture technician VAS scores. Wound blanching was judged to be less with Mepivanor than with TAC, although this difference was not statistically significant. There were no adverse reactions, wound infections, or healing difficulties for any of the patients who received TAC or Mepivanor. It was concluded that non-cocaine-containing Mepivanor was generally less effective than TAC and lidocaine infiltration in providing adequate local anesthesia during laceration repair. TAC containing only 120 mg of cocaine (3 mL of 4% cocaine) was as effective as 1% lidocaine infiltration in providing local anesthesia during laceration repair. This will allow the amount of cocaine in TAC to be reduced, thereby decreasing costs and the likelihood of adverse reactions.

Adolescent↗

New non-cocaine-containing topical anesthetics compared with tetracaine-adrenaline-cocaine during repair of lacerations.

OBJECTIVE: To compare the effectiveness of three new topical anesthetics that do not contain cocaine (prilocaine-phenylephrine, tetracaine-phenylephrine [tetraphen], and tetracaine-lidocaine-phenylephrine) to that of tetracaine-adrenaline-cocaine (TAC) during laceration repair in children. DESIGN: Prospective, randomized, double-blind clinical trial. SETTING: The emergency department of an urban children's hospital. PARTICIPANTS: Children 1 year of age or older with a laceration </= 5 cm in length that required suturing. Intervention. A total of 240 children were randomly assigned to one of four treatment groups. OUTCOME MEASURES: Pain felt during suturing was scored by suture technicians, research assistants, parents, and patients >/= 5 years of age using a visual analogue scale (VAS). Suture technicians, research assistants, and parents also scored pain using a seven-point Likert scale. In addition, suture technicians completed an anesthetic effectiveness scale. RESULTS: There was consistently no difference demonstrated between the effectiveness of tetraphen and that of TAC for each outcome measure of each observer group. A statistically significant difference was seen among anesthetics when comparing VAS and Likert scale scores of suture technicians and Likert scale scores of research assistants. Based on post hoc analyses, these statistically significant differences were between TAC and prilocaine-phenylephrine (suture technician VAS and Likert scale) and between TAC and tetracaine-lidocaine-phenyl-ephrine (suture technician Likert scale), but not between TAC and tetraphen. When power analyses were performed using alpha = 0.05 and beta = 0.20, it was possible to detect a difference of 1.2 VAS units for each of the observer groups. Based on anesthetic effectiveness scale scores, the three new topical preparations collectively performed significantly better on the face and scalp than on the extremities (relative risk = 1.83; 95% confidence interval 1.20 < relative risk < 2.79). CONCLUSION: This study demonstrated the effectiveness and safety of three new non-cocaine-containing topical anesthetics. Consistently, there was no statistical difference demonstrated between the effectiveness of tetraphen and that of TAC for each outcome measure of each observer group. Tetraphen offers an effective alternative to TAC during laceration repair in children.

Adolescent↗

Population requirements for capitation planning in pediatric cardiac surgery.

OBJECTIVE: To determine the population number necessary to generate a sufficient volume of pediatric cardiac surgeries to allow accurate prediction of resource utilization. DESIGN: All pediatric cardiac surgical patients receive care in our institution by means of only four clinical pathways that are based on acuity, not diagnosis or procedure. This allows accurate tracking of resource utilization. Based on available information, 750 consecutive surgically treated patients were retrospectively assigned to a pathway. They were subsequently subdivided into study groups of decreasing sizes from 150 to 35. Variability of pathway distribution from group to group was examined as a measure of the ability to predict resource utilization based on group size. Pediatric cardiac statistics from the state of Ohio were then used to extrapolate to the population base necessary to generate each group size. SETTING: A regional pediatric cardiac referral center. PATIENTS: All sequential patients who underwent pediatric cardiac surgery between July 1991 and January 1994. RESULTS: Statewide statistics showed that a population base of 1 million people generates 100 pediatric cardiac operations. Groups of 100 patients or greater had minimal variation in pathway distribution from group to group, allowing accurate prediction of hospital charges. This was not true for groups of 50 patients or less. CONCLUSIONS: Resource utilization for pediatric cardiac surgery can be accurately predicted in a capitated setting for populations of 1 million covered lives (100 procedures) or greater. For populations of 500 000 covered lives or less, variability of case mix is great enough to suggest the need for a more individualized payment mechanism.

Capitation Fee↗

Comparison of topical anesthetics without cocaine to tetracaine-adrenaline-cocaine and lidocaine infiltration during repair of lacerations: bupivacaine-norepinephrine is an effective new topical anesthetic agent.

OBJECTIVE: To compare the effectiveness of four topical anesthetics that do not contain cocaine with that of topical tetracaine-addrenaline-cocaine (TAC) and lidocaine infiltration during laceration repair in children. DESIGN: This was a randomized, blinded trial. SETTING: The study was conducted in the emergency department of a large children's hospital. PARTICIPANTS: Subjects were children 2 years of age or older with a laceration 5 cm or less in length that required sururing. INTERVENTIONS: Patients were randomly assigned to receive one of four noncocaine-containing topical anesthetics, topical TAC, or lidocaine infiltration anesthesia before laceration repair. OUTCOME MEASURES: Outcome measures assessed pain perceptions using a Visual Analogue Scale, Likert scale, and Anethetic Effectiveness scale. Distress behaviors of patients were measured with the Restrained Infants and Children Distress Rating Scale. RESULTS: Two hundred forty patients were enrolled in the study. Using alpha = 0.05 and beta = 0.2, there was statistical power to detect differences of 0.3 to 1.3 U for the outcome measures used. The bupivacaine-norepinephrine topical solution (Bupivanor) performed better than the other three new topical preparations. It provided effective wound anesthesia during lacertion repair, especially for lacerations of the face and scalp, where it was consistently rated as effective as TAC and 1% lidocaine infiltration by all observer groups for all outcome measures. There was a 4% overall wound complication, including one wound infection. CONCLUSION: Bupivanor is an effective alternative to TAC and lidocaine infiltration for local anesthesia during laceration repair, expecially on the face and scalp. The effectiveness of Bupivanor on the face is important, because it is here where TAC is most likely inadvertently to come into contact with mucous membranes and result in systemic toxicity. Because pain and distress scores did not take into consideration the pain associated with the initial injection of lidocaine, the findings of this study conservatively estimate Bupivanor's effectiveness, compared with lidocaine infiltration.

Administration, Cutaneous↗

Seizure classification in dogs from a nonreferral-based population.

On initial evaluation for onset of seizure disorders at nonreferral veterinary practices, 50 previously healthy dogs were enrolled in a study to determine the probability of identifying a specific cause for the seizures. Treatment was not administered prior to entry of dogs in the study. On the basis of antemortem and postmortem test results, 22 dogs (44%) were classified as having primary epileptic seizures (PES; idiopathic or without identifiable cause), 23 (46%) had secondary epileptic seizures (SES; identifiable intracranial cause), and 5 (10%) had reactive epileptic seizures (RES; metabolic or transient noxious cause). Forty-one dogs (82%) had 2 or more seizures before evaluation, with 37 (90%) of these dogs classified as having epilepsy on the basis of an underlying chronic brain disorder. For these 41 dogs, 17 (41%) had PES, 20 (49%) had SES, and 4 (10%) had RES. Among the 9 dogs (18%) with nonrecurring seizures, 5 had PES, 3 had SES, and 1 had RES. Generalized seizures were the most common first-observed seizure type associated with all etiologic classifications in all dogs with recurring and nonrecurring seizures. Diagnosis of SES was statistically more probable when the dog was less than 1 or more than 7 years old at the first seizure, when the first seizure was a partial seizure, or when the first seizure occurred between midnight and 8 AM. A diagnosis of RES was statistically more probable only when the interval between the first and second seizure was brief (< or = 4 weeks).(ABSTRACT TRUNCATED AT 250 WORDS)

Age Factors↗

Clinical pathways can be based on acuity, not diagnosis.

The standardization of medical practice is gaining acceptance as a technique for controlling length of stay and hospital charges, while maintaining quality. Most clinical pathways address specific diagnoses or procedures, but we have developed a new approach in which pathways for cardiac care are based on acuity. All congenital cardiac surgical care rendered at Columbus Children's Hospital now falls within one of four such clinical pathways. This simplified approach is easy to use and has been well accepted. Our experience in a group of 107 consecutive patients treated in this fashion is described. The results of variance analyses, along with length of stay and charge data, are presented to demonstrate the degree to which resource utilization can be standardized in this widely variable group of patients whose problems were made cohesive by classification according to acuity level. We conclude that the resultant standardization offers considerable advantages for the managed care environment.

Cardiac Surgical Procedures↗

Accuracy of references and quotations in veterinary journals.

The accuracy of references and quotations used to substantiate statements of fact in articles published in 6 frequently cited veterinary journals was examined. Three hundred references were randomly selected, and the accuracy of each citation was examined. A subset of 100 references was examined for quotational accuracy; ie, the accuracy with which authors represented the work or assertions of the author being cited. Of the 300 references selected, 295 were located, and 125 major errors were found in 88 (29.8%) of them. Sixty-seven (53.6%) major errors were found involving authors, 12 (9.6%) involved the article title, 14 (11.2%) involved the book or journal title, and 32 (25.6%) involved the volume number, date, or page numbers. Sixty-eight minor errors were detected. The accuracy of 111 quotations from 95 citations in 65 articles was examined. Nine quotations were technical and not classified, 86 (84.3%) were classified as correct, 2 (1.9%) contained minor misquotations, and 14 (13.7%) contained major misquotations. We concluded that misquotations and errors in citations occur frequently in veterinary journals, but at a rate similar to that reported for other biomedical journals.

Periodicals as Topic↗

Statistical considerations in pharmacokinetic study design.

Pharmacokinetic studies may generally be categorised into 3 types: (a) population-based investigations, (b) individual-based compartmental, or (c) individual-based noncompartmental research projects. Each type of study has advantages and limitations. Population-based investigations pool drug concentrations across more than 1 individual subject. From these data, estimates of pharmacokinetic parameters are calculated. NONMEM is the only computer program available to evaluate this type of information. Recently a method has been proposed which derives individual estimates from the information available from NONMEM. By combining these 2 procedures it is possible for the clinician to review and adjust the dosage regimen if necessary. Population-based studies require fewer design criteria than other methods and are adaptable to the clinical setting, i.e. subjects can be patients currently being treated with the drug under consideration. One distinct advantage to this type of study is the flexibility of sampling times and the capability of the clinician to use information from the critically ill, the geriatric patient or the very young child. These subjects would not be available for the individual-based type of study because of the relatively large number of samples needed. Individual-based pharmacokinetic studies can be divided into 2 types with respect to their evaluation: (a) compartmental and (b) noncompartmental investigations. The latter type of study was originally thought to require fewer assumptions than the former but subsequently it has been shown that noncompartmental analyses are more restrictive and are basically compartmental in their approach. These studies estimate parameters which the compartmental investigation does not usually consider. These include area under the moment curve (AUMC) and mean residence time (MRT).(ABSTRACT TRUNCATED AT 250 WORDS)

Humans↗

The lipid composition of milk from mice fed high or low fat diets.

Total fatty acids and the proportions of methyl esters of individual fatty acids were measured in mouse milk. Pregnant mice were fed either a high fat (HF) diet or a low fat (LF) diet from 14 days of gestation. After parturition, each dam was milked once a day for a period of 18 days. The mean total fatty acid concentration over the entire study period was 110 mg/g of milk (approximately 11.7% fat as triglyceride) for both dietary treatment groups. During days 2 to 6 postpartum, the mean total fatty acid concentration for dams fed HF diet was lower than for the LF group. Although the concentration of total fatty acids of mouse milk was not affected by the level of dietary fat fed to the dam, several variations in the proportions of individual fatty acids were observed.

Animals↗

Body weights of C3H/HeN mice fed semipurified or commercial diets of different fat content.

Oncology studies often require specially formulated diets to be fed to laboratory animals. To determine the effect of dietary fat on body weight, C3H/HeN mice were carefully assigned by weight into three groups. The first group was fed a high-fat semipurified diet (23% fat by weight) from 21 to 73 days of age then returned to a low-fat semipurified diet (5% fat by weight). A second group was fed the low-fat diet from 21 to 73 days of age, then the high-fat diet until 129 days of age, then returned to the low-fat diet. A final group was fed a 4.5% fat commercial diet for the entire 193-day study. The results showed that the mice fed the semipurified diets did not differ significantly from each other in weight over the course of the study but did differ significantly between 21 and 73 days of age, possibly from a taste preference for the high-fat diet. Mice fed the commercial diet always weighed significantly less. It was estimated that mice fed the commercial diet consumed more food and were less efficient in their food utilization. Mice should be carefully assigned, by weight, into experimental groups, and all groups, including untreated controls, should be fed the same type of diet.

Analysis of Variance↗

Construction of best confidence intervals for half-lives.

This paper presents a method of determining a confidence interval for the drug half-life based on statistical properties of the estimates of the disappearance rate constant of the drug. This interval is shown to be of minimum length which indicates it is a more precise estimate than others currently in use. A computer program to construct these intervals is available upon request.

Confidence Intervals↗