Uses of epoetin for anemia in oncology.
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Anemia, Hemolytic↗
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Results for “Randomized Response Technic”
Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
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[Comparison of 2 types of experimental transplant in the treatment of lethal short bowel syndrome].
OBJECTIVE: To evaluate the functional response, morbidity and histostructural changes in rats enterectomized and without cecum using two types of syngenic enteral transplants. MATERIAL AND METHODS: Controlled randomized surgical-therapeutic trial. Four groups of male Lewis rats 8-10 weeks old underwent the following procedures: 1. Lethal enteral resection (n = 10). 2. Lethal enteral resection + total yeyuno-ileal transplant (n = 28). 3. Lethal enteral resection + distal segmentary of 40% and cecum transplant (n = 32). 4. Control group (n = 10). RESULTS: 11% of the transplanted animals died due to technical failures; both transplanted groups had a similar proportion of late complications, mostly enteral obstruction. A persistent diarrhea was observed in 20% of the yeyuno-ileal transplanted group, but no significant differences were found between the two groups concerning survival, weight gain, protein and triglycerides serum levels, and a maltose absorption test; villus and crypt hypertrophy was observed in both grafts. The enteral graft integration was followed by structural changes similar to those found in intestinal remnants on deficit conditions after enteral resection. CONCLUSION: The bowel distal segmentary transplant with ileocecal valve and cecum may be a good option in cases of irreversible enteral failure, as the functional response and morbidity are similar to those found with the standard total transplant.
Animals↗
On the role, design, and analysis of disease prevention trials.
Some differences between prevention and therapeutic trials are reviewed, as are some of David Byar's contributions to the methodology and practice of prevention trials. This leads to a more detailed discussion of three more technical topics pertinent to prevention trials: (i) the role that aggregate data studies may be able to play to complement analytic epidemiologic studies and prevention trials in the identification of disease prevention strategies; (ii) the methods for analysis of correlated response data, as may arise in group randomized trials; and (iii) the importance of emphasizing overall benefits vs. risks in the design and conduct of disease prevention trials.
Biometry↗
Technical skills required in general pediatric practice.
Several years ago the American Board of Pediatrics developed a list of 101 technical procedures, which was sent to directors of accredited pediatric programs (N = 231). There was a 70% response and 72 of 101 procedures were considered necessary for residents to develop competency by at least 80% of the program directors. The list of 72 procedures was then sent to 500 randomly selected general pediatricians from a pool size of 10,304. The response rate was 35%. Forty-nine of the 72 procedures were considered necessary by 80% of those responding and one third of the skills (24 of 72) could be classified as absolutely necessary because more than 95% of practitioners considered them to be. Only 7 procedural skills were considered unnecessary by more than 50% of practitioners. It is suggested that program directors consider the 24 skills as ones that should be taught and competence in performing them be verified and recorded.
Child↗
The application of EMLA and glyceryl trinitrate ointment prior to venepuncture.
The efficacy of EMLA cream combined with glyceryl trinitrate (GTN) ointment was assessed by a double-blind prospective study. Adult female patients were randomly allocated to receive either EMLA 1 ml or 2 ml combined with GTN 2 mg, or EMLA 2 ml only. The difference in pain scores between the three groups was not statistically significant. When GTN was used with EMLA, the quality of the veins was superior and aided intravenous cannulation. There were no significant side-effects. It is concluded that if GTN is used with EMLA, the dose of EMLA can be reduced and intravenous cannulation is technically easier compared with EMLA alone.
Adult↗
Optimal electrode placements for adequate spatial sampling of auditory evoked potentials.
When evoked responses are used in clinical practice and research the measures that are most commonly considered are the latencies and amplitudes of EP components as measured at a single electrode site. Our recent studies have shown that multichannel recordings yield measures such as potential field asymmetry that may be as important as component latency and amplitude. The purpose of this short technical note is to suggest that electrode placement is critical for demonstrating interesting features of the potential field topography, specifically, bilateral, homologous generator sites. The cortical imaging technique (CIT) was used to analyze the averaged responses for a group of thirty normal young adults to a repeated tone and a random oddball tone. Recordings were obtained at 28 scalp recording sites which included 20 placements from the 10-20 system and eight additional sites. Simulated cortical maps were derived for four components, the N1 frequent response and the N2a, P3, and N3, rare minus frequent responses for three different electrode arrays. These arrangements included the full 28-channel array, a 20-channel array that excluded eight additional central sites, and a 20-channel array that included the eight additional sites and excluded peripheral sites. This study demonstrates that for these auditory paradigms, the placement of the electrodes is critically important for discriminating important features of the potential fields.
Acoustic Stimulation↗
Pharmacist staffing, technology use, and implementation of medication safety practices in rural hospitals.
CONTEXT: Medication safety is clearly an important quality issue for rural hospitals. However, rural hospitals face special challenges implementing medication safety practices in terms of their staffing and financial and technical resources. PURPOSE: This study assessed the capacity of small rural hospitals to implement medication safety practices, with particular focus on pharmacist staffing and the availability of technology. METHODS: A telephone survey of a national random sample of small rural hospitals was conducted from March to May 2005 (N = 387 hospitals, 94.6% response rate). Survey respondents included pharmacists (89%) and directors of nursing (11%). Multivariate analyses examined the relationships between hospital organizational and financial variables and (1) the amount of pharmacist staffing; (2) use of pharmacy computers for medication safety activities; and (3) implementation of medication safety practices. FINDINGS: Many small rural hospitals have limited hours of on-site pharmacist coverage. Almost one quarter of hospitals either do not have a pharmacy computer or are not using it for clinical purposes. Half of the hospitals have implemented 4 key medication safety practices. Level of pharmacist staffing, use of technology, and implementation of medication safety practices are significantly related to hospital financial status and accreditation. CONCLUSIONS: Implementation of protocols related to medication use and key medication safety practices are areas where small rural hospitals could improve. The study results support a continuation of Medicare cost-based reimbursement policies to help ensure financial stability and support quality and patient safety activities in small rural hospitals.
Clinical Protocols↗
HER2 testing: laboratory, technical and clinical considerations.
HER2 measurement holds great promise in predicting response to a variety of systemic therapies an exciting step forward in the management of breast cancer patients. The enthusiasm surrounding the clinical importance of HER2, however, is tempered by the uncertainty regarding the clinical usefulness and accuracy of the different methodologies currently available to assess HER2 status. In this paper the authors address laboratory and technical issues associated with methods which measure HER2 overexpression or amplification. We also discuss how these issues can influence the clinical utility and routine application of this marker. While a tumor marker may be considered clinically relevant, it must be proven to be clinically useful. Optimally, this should occur in the setting of a randomized clinical trial, using methods that are reliable, reproducible, and biologically accurate. For HER2 testing to be a useful, routine clinical marker several critical issues need to addressed. These include the determination and validation of the clinical utility of each method to predict response to the different systemic therapies currently associated with HER2. In addition, there is need to set standards for assay performance and interpretation of assay results, based on criteria that are clinically validated.
Journal Article↗
A phase II randomized study comparing sequential and combined intraarterial cisplatin and radiation therapy in primary brain tumors. A Southwest Oncology Group study.
The Southwest Oncology Group conducted a trial of intra-arterial cisplatin (150 mg intravenously every 21 days for 2 doses) administered concomitant with or before radiation therapy. Because of technical difficulties cannulating the artery, 27 of 33 eligible patients were able to receive the cisplatin by arterial injection. Five patients died before completion of the study, and 11 patients in each treatment arm were evaluable for response. Three patients (27%) had an objective tumor regression in each treatment arm. Thromboembolic problems complicated 8 of 57 (14%) chemotherapeutic courses. The median survival for the 33 eligible patients was comparable for both groups: 10.8 months in the concomitant treatment arm and 9.6 months with sequential therapy. Problems related to drug administration and toxicity made it impossible to determine the role of intraarterial cisplatin in the initial management of primary high-grade gliomas.
Adolescent↗
Hepatic artery ligation with and without portal infusion of 5-FU. A randomized study in patients with unresectable liver metastases from colorectal carcinoma. The E.O.R.T.C. Gastrointestinal Cancer Cooperative Group (G.I. Group).
The aim of this multicentric prospective randomized clinical trial was to study the efficacy of hepatic artery ligation (HAL) with and without portal infusion (PI) of 5-FU in patients with liver metastasis of colorectal origin. Seventy-four patients were randomized. Sixty-seven were fully evaluable. Thirty-five patients were eligible in the HAL + PI of 5-FU group and 32 in the HAL alone group. The 5-FU infusion had to be discontinued for technical reasons in 13 patients. Complications of HAL were relatively high, including four hepatic failures (WHO grading greater than 2). Side effects of chemotherapy were limited. Five patients out of 30 had a partial response (WHO criteria) and one patient had a complete response in the group treated by HAL and PI of 5-FU. Only one patient had a partial response in the HAL alone group. Median survival for both groups was 12 months. Median time to progression for both groups was 6 months. This study did not show any advantage of delivery using the portal route in addition to hepatic artery ligation in terms of progression nor in survival of patients.
Adenocarcinoma↗
Design-based stereological estimation of hepatocyte number, by combining the smooth optical fractionator and immunocytochemistry with anti-carcinoembryonic antigen polyclonal antibodies.
BACKGROUND/AIMS: Hepatocytes (HEP) have been the major target for structural quantification in the liver, but an estimation of their total number (N), their percentage in relation to the global number of liver cells and the evaluation of the percentage of binucleated hepatocytes (BnHEPs) have never been performed with modern design-based stereological techniques. The establishment of sound technical guidelines and baseline quantitative data in non-pathological conditions are relevant to properly evaluate HEP hyperplasia and BnHEP responses. METHODS: In this study, we combined immunocytochemistry with sound design-based stereology for estimating the N of HEP and the N of non-hepatocytic cells (NHCs). For obtaining systematic uniform random sections (30 microm thick), a smooth fractionator sampling scheme was applied to the liver of five male Wistar rats (3 month old). Those sections were immunostained with polyclonal antibodies against carcinoembryonic antigen. Because biliary canaliculi were then marked, an unequivocal counting of mononucleated hepatocytes (MnHEP) and BnHEP was allowed. RESULTS: The N of HEP was estimated to be 1.93 x 10(9), with a coefficient of error (CE) of 0.02, corresponding to 129 x 10(6) HEP/g of liver. BnHEP represented 26% of total HEP number. The N of NHC was estimated as 1.31 x 10(9) (CE=0.02). CONCLUSION: The strategy here presented provides a reliable method for accessing the N of HEP (distinguishing MnHEP from BnHEP) in situations in which these parameters are relevant, namely for evaluating the magnitude of an hyperplastic liver response from its very early onset.
Animals↗
Sleep induction for EEG revisited: technical note.
Forty-two patients each were randomly assigned in equal numbers to receive either zolpidem or secobarbital for sleep EEG recording. Three groups were compared; zolpidem, secobarbital and a control group of patients who drowsed spontaneously. All patients were evaluated before and immediately after the EEG and several hours later with measures of anxiety, perceptual-motor performance, locomotion, and subjective judgments of sleepiness. EEG response to standard activation procedures, signs of drowsiness and sleep and overall diagnoses were compared among the three groups. No differences emerged in demographic measures, psychiatric diagnoses, current drug treatment and experience with hypnotics. There were no statistically significant differences among the three groups or between the patients receiving the hypnotics on the anxiety performance and locomotion measures or degree of alertness. As a result of the experimental design, the unmedicated control patients showed EEG signs of drowsiness and sleep significantly sooner than patients receiving hypnotics. They also showed more slow or paroxysmal activity in response to hyperventilation, which may have been due to their greater effort. These results led us to retain secobarbital as the hypnotic for EEG sleep, mainly for economic reasons.
Adult↗
Evaluation of the usefulness of dimethicone and/or senna extract in improving the visualization of abdominal organs.
Intestinal gas is the most common cause of technically unsatisfactory abdominal ultrasound scans. In the attempt to increase the visualization of abdominal organs, many investigators use antifoaming agents or laxatives. In the present, randomized, placebo-controlled, double-blind trial, a liquid dimethicone preparation and an extract of senna, alone and in combination, were tested as a means to improve scan quality. Response variables were defined on the basis of pancreas, aorta, and kidney visibility. There was no difference in the response variables of the three groups compared to placebo (P greater than 0.3-0.55). The results suggest that neither dimethicone nor senna improves the visibility of abdominal organs in ultrasound examination.
Abdomen↗
An internet-based survey method for college student drinking research.
The purpose of this study was to describe and assess the utility of an Internet-based survey method for characterizing the alcohol consumption of college students. After extensive pilot research, a random sample of 1910 students aged 16-29 years was invited to complete a questionnaire, consisting of a series of web-pages linked to a relational database on a secure web-site. A branch structure allowed for tailoring of survey items by age and gender. The students received up to nine contacts, including a pre-notice letter with a token gift and an e-mail invitation (Phase 1), a reminder letter and e-mail message (Phase 2), and then telephone reminders and replacement access codes (Phase 3). Non-computer-users were offered a pen-and-paper alternative, making this a mixed-mode survey. The overall response to the survey was 82% (n = 1564). The median completion time was 16.7 min. Participants' comments showed high levels of satisfaction with the survey. Comparison of web (n = 1501) versus pen-and-paper completions (n = 63) revealed no modality effects. Technical problems addressed during the course of implementation included web-browser-operating system incompatibilities, and periodic network errors, although these resulted in little lost participation. Internet-based surveys are feasible for college student research and with carefully managed recruitment, can yield a high response.
Adolescent↗
[Non-small-cell bronchial cancers: improvement of survival probability by conformal radiotherapy].
The conformal radiotherapy approach, three-dimensional conformal radiotherapy (3DCRT) and intensity-modulated radiotherapy (IMRT), is based on modern imaging modalities, efficient 3D treatment planning systems, sophisticated immobilization devices and demanding quality assurance and treatment verification. The main goal of conformal radiotherapy is to ensure a high dose distribution tailored to the limits of the target volume while reducing exposure of healthy tissues. These techniques would then allow a further dose escalation increasing local control and survival. Non-small cell lung cancer (NSCLC) is one of the most difficult malignant tumors to be treated. It combines geometrical difficulties due to respiratory motion, and number of low tolerance neighboring organs, and dosimetric difficulties because of the presence of huge inhomogeneities. This localization is an attractive and ambitious example for the evaluation of new techniques. However, the published clinical reports in the last years described very heterogeneous techniques and, in the absence of prospective randomized trials, it is somewhat difficult at present to evaluate the real benefits drawn from those conformal radiotherapy techniques. After reviewing the rationale for 3DCRT for NSCLC, this paper will describe the main studies of 3DCRT, in order to evaluate its impact on lung cancer treatment. Then, the current state-of-the-art of IMRT and the last technical and therapeutic innovations in NSCLC will be discussed.
Carcinoma, Non-Small-Cell Lung↗
Fast neutron and mixed beam radiotherapy for inoperable non-small cell carcinoma of the lung. Results of an RTOG randomized study.
From July 1979 through March 1984 the Radiation Therapy Oncology Group conducted a randomized study comparing fast neutron radiotherapy versus mixed beam (neutron/photon) radiotherapy versus conventional radiotherapy for patients with non-small cell carcinoma of the lung. Patients were either medically or technically inoperable. One hundred two evaluable patients were placed on the study. The radiation doses were approximately 60 Gy-equivalent on each arm. Patients were stratified according to size of primary, histology, Karnofsky performance status, and age distribution. Overall local response rates as measured by serial radiographs were the same on the three arms, and an actuarial analysis showed no significant differences in either median or long-term survival. However, for the subgroup of patients exhibiting a complete or partial tumor response at 6 months there was a suggestion of improved 3-year survival on the two experimental arms (mixed beam, 37%; neutrons, 25%; photons, 12%). The p value for the difference between the mixed beam and photon curves is 0.14 (two-sided test). The incidence of major complications was higher on the neutron and mixed beam arms. These complications included four cases of myelitis which are analyzed in detail. The results are placed in the context of other published work on the use of neutrons in the treatment of lung cancer.
Fast Neutrons↗
[Surgical morbidity for bronchial cancers after neoadjuvant treatment].
Two randomized trials, in 1994, have demonstrated the benefit of neoadjuvant chemotherapy, in term of median survival, for stage III lung cancer. Further studies have evaluated the potential benefit of chemotherapy or chemotherapy-radiotherapy association, either for patients suitable for surgery, or for non resectables tumors. However, these treatments treatments may increase the morbidity of surgery. Such an increase has not been demonstrated, except in one study, after chemotherapy alone before surgery. When radiation therapy is associated with pre-operative chemotherapy, the risk of complications seems to be dose dependent: low for doses below 50 Gy, important for doses over 55 Gy. These datas justify pre-operative lung function measurements and modifications of the surgical technic, especially for the lymphadenectomy extension. Despite this potential increase of morbidity, the benefit of neoadjuvant treatment is real.
Antineoplastic Agents↗
Satisfaction of mothers by nursing care provided to their sick children in ambulatory health care centers.
The aim of the study was to measure satisfaction of mothers attending health units with their ambulatory children. A random sample of 150 mothers was included in the study from 3 ambulatory care units in Ismailia. The indirect method of measuring satisfaction was used through identification of mothers pre-visit expectations and measuring the post visit fulfillment by technical quality of nursing care. The percentage of expectation fulfillment reflected the degree of satisfaction. The mother's responses were validated by observers opinion to the same service provided. The results of the study revealed that respondent scores indicated a weak satisfaction with most of nursing care services such as taking temperature, weighing the child and carrying physicians orders. The results also revealed that aspects related to nurse's advice and guidance to mothers regarding child's condition, elicited high level of unsatisfaction.
Ambulatory Care↗