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At least 73 records · Page 4Linked to original sources
PubMed1992

Quality-of-life assessment in cancer treatment protocols: research issues in protocol development.

BACKGROUND: Interest in incorporating quality of life as an end point in clinical studies of cancer treatment has intensified in recent years. PURPOSE: We provide practical suggestions that will assist investigators considering including quality-of-life assessment in phase III therapeutic trials. METHODS: We discuss issues important in study planning, including quality-of-life definition, priority studies for quality-of-life assessment, eligibility requirements, and design. CONCLUSIONS: Many of the problems that quality-of-life studies have encountered, from protocol approval to data analysis, could be addressed and alleviated during protocol development. This discussion is intended to assist and stimulate investigators conducting research in this area.

Clinical Protocols↗
PubMedDate not supplied

Practical protocols for the prevention of dental disease in community settings for people with special needs: the protocols.

People with special needs have more dental disease and more missing teeth than the general population. They also have reduced access to oral health diagnostic, preventive, interceptive and treatment services. If services are available, they can be complicated and costly. It is critical to prevent dental diseases in these individuals. This article presents a set of practical protocols for preventing dental disease in people with special needs. These protocols are designed to be used in community settings outside of a dental office.

Anti-Infective Agents, Local↗
PubMed2005

A new protocol for maxillary protraction in cleft patients: repetitive weekly protocol of alternate rapid maxillary expansions and constrictions.

OBJECTIVE: It was hypothesized that, through a repetitive weekly protocol of Alternate Rapid Maxillary Expansions and Constrictions (Alt-RAMEC), the maxilla in cleft patients could be protracted more effectively than with a single course of rapid maxillary expansion (RME). METHODS: Twenty-six consecutive unilateral cleft lip and palate patients at the age of mixed dentition were included in this prospective clinical study. The rapid maxillary expansion group included the first 16 consecutive patients undergoing 1 week of rapid maxillary expansion (1 mm/day) followed by 5 months, 3 weeks of maxillary protraction. The Alternate Rapid Maxillary Expansions and Constrictions group included the next 10 consecutive patients undergoing 9 weeks of Alternate Rapid Maxillary Expansions and Constrictions followed by 3 months, 3 weeks of maxillary protraction. Daily activation of the weekly expansion or constriction was 1.0 mm. Two-hinged expanders and intraoral maxillary protraction springs were used in both groups. Treatment results were evaluated cephalometrically. RESULTS: The amount of maxillary anterior displacement by the 2-hinged expander in the Alternate Rapid Maxillary Expansions and Constrictions group was 3.0 +/- 0.9 mm at A point, significantly greater than the 1.6 +/- 1.0 mm in the rapid maxillary expansion group. The amount of maxillary advancement with intraoral protraction springs in the Alternate Rapid Maxillary Expansions and Constrictions group was 2.9 +/- 1.9 mm at A point, significantly greater than the 0.9 +/- 1.1 mm in the rapid maxillary expansion group. The overall amount of maxillary advancement in the Alternate Rapid Maxillary Expansions and Constrictions group was 5.8 +/- 2.3 mm at A point. This result remained stable, without significant relapse after 2 years. CONCLUSIONS: Maxillary protraction using the 2-hinged expander, a repetitive weekly protocol of Alternate Rapid Maxillary Expansions and Constrictions, and intraoral protraction springs is most effective, with stable results at 2-year follow-up.

Cephalometry↗
PubMedDate not supplied

[The role of protocols as indicator of "process" in a Department of Anesthesiology-example of an anesthetic protocol for lung transplantation].

This paper is aimed at to demonstrate and enhance the importance of anesthetic protocols in general sense, and for the lung transplantation in particular, as markers of "process" in the perioperative anesthetic care. The authors describe and discuss the main steps of the organization of a specific protocol dedicated to lung transplantation and put particular emphasis on the need of a good integration of the different specialties and professional groups directly involved in this demanding field of activity.

Anesthesia↗
PubMed1990

[Clinical Evaluation of protocol for the craniomandibular disorders. 1. Protocol of our department].

Craniomandibular disorders are conditions encompassing various types of dysfunction of the stomatognathic system. To define the very nature of morbidity, both differential and pathological diagnosis are absolutely necessary. At present, each medical institution in this country has its own protocol for evaluating and treating craniomandibular disorders. This makes it difficult to exchange and compare data between institutions. In this paper, a protocol worked out by our department after a series of clinical tests and study is presented, and its merits and unresolved problems are discussed.

Clinical Protocols↗
PubMed1984

[Comparative study of the efficacy of the DBVCy protocol (daunoblastin, bleomycin, vincristine, cytostasan) and the ABVD protocol in advanced Hodgkin's lymphoma. A prospective inter-clinic study within the framework of the Hauptforschungsrichtung Geschwulsterkrankungen].

In MOPP-resistant patients with Hodgkin-lymphoma stage III B and IV the well known ABVD-protocol was compared with the DBVCy-protocol (daunorubicin, bleomycin, vincristine, cytostasan) in a randomized prospective trial. 73 patients were evaluable, 35 received ABVD, 38 DBVCy. 4 out of 35 (11%) in the ABVD-group and 9 out of 38(24%) in the DBVCy-group reached complete remission. The median duration of the remission for DBVCy was 4,5 months, for ABVD 3,4 months (no significance). Median survivals (61 months in DBVCy and 37 months in ABVD) did not show significant differences; but the DBVCy-scheme seems to be better tolerabel. With the given evaluation can not be proved a difference between the two groups, but it is not likely, that one of the regimen is very much better or very much worse as the other.

Adult↗
PubMedDate not supplied

[Morbid obesity. Reflections on a surgical protocol (I). A clinical and peroperative protocol].

UNLABELLED: Obesity as a condition, and morbid obesity as a disease, have at present reached epidemic proportions. Bariatric surgery is the most effective treatment in those patients in whom medical, dietary, and/or behavioral treatments have failed. What is more, it is the initial treatment of choice in morbid superobese patients (> 50 kg/m2). The present study summarizes and criticizes the main surgical techniques used at present, and purposes an action protocol for anesthesia, as well as some norms and advice on control, action, and pulmonary and dietary rehabilitation, in the peri- and post operative period, based on more than 7 years' experience with a series of more than 150 operated and controlled patients. CONCLUSION: A restrictive bariatric technique is a model which allows the multidisciplinary obesity treatment team to achieve a definite and permanent modification of the eating habits of all patients who meet the criteria for inclusion in a surgical protocol.

Anesthesia↗
PubMed1996

Legal aspects of therapist-driven protocols. Do therapist-driven protocols place therapists in a legally compromising position?

The recent introduction of therapist-driven protocols has given the appearance of restricting the professional judgment of respiratory therapists with decision-tree robotics while contemporaneously catapulting them into the practice of medicine. This is happening in the midst of a spiraling litigation climate. This article examines the legal aspects--from malpractice to licensure--of this exciting new practice known as therapist-driven respiratory protocols.

Clinical Protocols↗
PubMed2002

Comparison of toxicity studies based on the draft protocol for the 'Enhanced OECD Test Guideline no. 407' and the research protocol of 'Pubertal Development and Thyroid Function in Immature Male Rats' with 6-n-propyl-2-thiouracil.

Two repeated-dose studies of 6-n-propyl-2-thiouracil (PTU) in male rats based on the research protocol 'Pubertal Development and Thyroid Function in Immature Male Rats' (pubertal assay) proposed by the Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC) and the draft protocol of the 'Enhanced OECD Test Guideline 407' (enhanced TG 407) were performed to investigate the suitability of both assays as screening methods for the detection of endocrine-mediated effects and to compare their sensitivity for the endocrine-mediated effects. In the pubertal assay, PTU at doses of 0, 0.01, or 1 mg/kg per day was orally administered to male Sprague-Dawley rats for 30 days, starting at 23 days of age. In the enhanced TG 407 the same doses of PTU were orally administered to male Sprague-Dawley rats for 28 days, starting at 7 weeks of age. In the pubertal assay, decreased serum thyroxine (T4) and triiodothyronine (T3), increased thyroid and pituitary weights, hypertrophy of follicular epithelial cells in the thyroid, and increased basophilic cells in the pituitary were detected as endocrine-mediated effects of PTU in the 1 mg/kg group. In the enhanced TG 407, decreased T4 and T3 were detected in both the 0.01 and 1 mg/kg groups, together with increased thyroid-stimulating hormone in the 1 mg/kg group, increased thyroid and pituitary weights in the 1 mg/kg group, and hypertrophy of follicular epithelial cells in the thyroid and increased basophilic cells in the pituitary of the 1 mg/kg group. Thus, among the parameters tested, the thyroid hormone levels, organ weight changes, and the histopathological assessment allowed detection of the endocrine-related effects of PTU in both the pubertal assay and the enhanced TG 407, but the sensitivity of the hormone analysis was higher in the latter.

Animals↗
PubMed2002

A protocol for the in vitro micronucleus test. I. Contributions to the development of a protocol suitable for regulatory submissions from an examination of 16 chemicals with different mechanisms of action and different levels of activity.

The in vitro micronucleus (IVM) test is currently used as a screen during the early stages of pharmaceutical development to identify chemicals likely to produce positive outcomes in the in vitro chromosome aberration assay. For several reasons, the assay is being considered as an alternative to the aberration assay, but the current screening protocols are not rigorous enough to fully satisfy concerns about genotoxic safety. This manuscript describes the investigation of several protocol parameters to assist with the development of a regulatory guideline for the IVM test. The parameters investigated are: the effect of cytochalasin B on the outcome of the assay when conducted with continually growing cell lines; the need for an extended exposure in the absence of metabolic activation; and the number of cells to be counted for a valid assay. In addition, two statistical procedures for the analysis of data from the test are described. The results of the investigation indicate that cytochalasin B does not effect the outcome of the test, that the extended exposure treatment is not necessary, that counting 2000 cells is preferable to counting 1000, and that the data can be appropriately analyzed using a trend test.

Animals↗
PubMedDate not supplied

Comparison of an oestrus synchronisation protocol with oestradiol benzoate and PGF2alpha and insemination at detected oestrus to a timed insemination protocol (Ovsynch) on reproductive performance of lactating dairy cows.

A total of 226 out of 245 postpartum lactating dairy cows in a commercial dairy farm were allocated to two groups of oestrous synchronisation protocols in order to evaluate reproductive performance. One group was treated with oestradiol benzoate (ODB) and PGF2alpha on day 10 of the oestrous cycle with insemination at the detected oestrus, the second group underwent the Ovsynch (OVS) protocol (GnRH + PGF2alpha + GnRH) with timed AI. Pregnancy was diagnosed by ultrasonography on day 28 after AI and confirmed by rectal palpation on day 45. A higher (P < 0.001) proportion of cows in OVS (100%) were inseminated within (19.2 +/- 3.8 h) following the second GnRH injection than those of cows in EPE (ODB + PGF2alpha + ODB) (70.6%) inseminated at the detected oestrus within (35.6 +/- 5.2 h) following the second ODB injection. Pregnancy rates for the first AI at day 28 (64.0 +/- 4.6, 62.4 +/- 5.5%) and at day 45 post-insemination (40.4 +/- 4.7, 40.0 +/- 5.6%) for OVS and EPE cows respectively, did not differ between the two treatments, whereas, the overall pregnancy rates tended to be higher (P < 0.08) for the OVS (85.1 +/- 3.8%) cows than the EPE cows (74.1 +/- 4.5%). No differences were observed in pregnancy rates for first AI and overall up to fourth AI between primiparous (34.7 +/- 5.8 and 85.3 +/- 4.7%) and multiparous cows (43.5 +/- 4.5 and 77.4 +/- 3.6%). Days open for pregnant cows tended to be lower (P < 0.08) for OVS (76.2 +/- 3) than for EPE cows (84.7 +/- 4), while days open were higher (P < 0.05) in primiparous cows (85.3 +/- 4) than in multiparous cows (75.6 +/- 3). The results indicate that pregnancy rates for first AI were similar, but overall pregnancy rates up to the fourth AI tended to be higher for OVS than EPE cows, while days open was tended to be lower for OVS than EPE cows.

Animals↗
PubMed1991

A protocol for the safe administration of debrisoquine in biochemical epidemiologic research protocols for hospitalized patients.

The genetically determined ability to metabolize the antihypertensive drug debrisoquine has been proposed as a genetic risk factor for primary carcinomas of the lung. To test this hypothesis, the metabolism of the drug was evaluated in a case control study. The subjects were characterized by their ability to metabolize debrisoquine after receiving a test dose of the drug followed by the collection of an 8-hour urine sample. They were classified by laboratory analysis into one of the following three groups: extensive, intermediate, and poor metabolizers. Poor metabolizers comprise 10% of the population and are unable to hydroxylate the drug. This group was expected to be at highest risk for deleterious effects from this medication. A protocol was created that included patient education and blood pressure monitoring to administer this medication safely to a group of patients with cancer who were already compromised. Although poor metabolizers showed a small decrease in systolic and diastolic blood pressure, no significant hypotensive episodes or clinical sequelae were observed in any of the groups. These data suggest that debrisoquine can be administered safely in a controlled clinical setting and will be useful for the characterization of lung cancer patients in biochemical epidemiology studies.

Blood Pressure↗
PubMed1995

Some surprising similarities in the clinical reasoning of 'expert' and 'novice' orthopaedic nurses: report of a study using verbal protocols and protocol analyses.

This paper reports on an Australian study of 'expert' and 'novice' orthopaedic nursing practitioners' clinical reasoning. Concurrent and retrospective verbal reports of patient assessment and care planning in real 'everyday' practice situations were collected from nine pairs of 'expert' and 'novice' orthopaedic nurses. Verbal protocol analyses revealed that the experts used the same level of concepts as novices, that their clinical reasoning was as physically orientated as that of novices, and that the implicit constructions of nursing in the reasonings of both experts and novices were consistent with a 'medical model' of health care. The research design, limitations and findings are discussed.

Adult↗
PubMed1989

The maximization test for skin sensitization potential--updating the standard protocol and validation of a modified protocol.

Since Magnusson and Kligman (1969) first described the maximization test, for assessing skin sensitization potential, the test has been substantially validated and data have been obtained on dose-activity relationships. The original method remains acceptable for qualified risk assessment but several modified protocols have been developed to overcome problems with particular test materials. A modified maximization test is described for compounds that are not soluble in the standard vehicles and, therefore, not injectable, and for formulations, to simulate user exposure conditions. The test compounds 2,4-dinitrochlorobenzene, p-phenylenediamine, 1-(3-chlorophenyl)-3- (4-chlorophenyl)-2-pyrazoline, formaldehyde, benzocain, penicillin G, benzylsalicylate, potassium dichromate and isoeugenol, all gave positive reactions. The incidences of positive reactions varied with the sensitization potentials of the compounds. The results for the first six compounds listed above were compared with those obtained by the standard procedure and were found to be similar. We propose that testing guidelines for skin sensitization should accommodate validated modifications of existing standard procedures.

Administration, Cutaneous↗
PubMed1996

The J-coupling restrained molecular mechanics (JrMM) protocol--an efficient alternative for deriving DNA endocyclic torsion angle constraints. Part II: Experimental application of the JrMM protocol.

The J-coupling restrained molecular mechanics (JrMM) protocol, which correlates deoxyribose endocyclic torsion angles and vicinal proton-proton torsion angle phi 1'2' in Part I of this study, is demonstrated to be a viable alternative to efficiently derive the endocyclic torsion angle constraints for the determination of the solution structures of DNA molecules. Extensive testing demonstrating the validity of the JrMM-derived torsion angle constraints in the restrained molecular dynamics and energy minimization structural refinement processes is performed theoretically using an energy-minimized B-DNA model and experimentally using a DNA hexamer d(CGTACG)2. The results show that only a 0.2 A difference exists between the RMSD values of the refined structures using the ideal and the JrMM-derived endocyclic torsion angle constraints. The JrMM-derived torsion angles are also determined to be in good agreement with the torsion angles derived through the use of the vicinal J-derived torsion angles. These results show that through the use of reliably measured J1'2' values and computer simulation method, the endocyclic torsion angle constraints can be derived reliably and efficiently. Thus the JrMM method serves as an alternative strategy to generate endocyclic torsion angle constraints for the determination of the solution structures of DNA molecules.

Computer Simulation↗
PubMed2001

Comparison of agonistic flare-up-protocol and antagonistic multiple dose protocol in ovarian stimulation of poor responders: results of a prospective randomized trial.

The management of poor responders in IVF has always been a big problem. The ideal approach has yet to be formulated. In this study we aim to compare two alternative stimulation protocols. A total of 48 poor responder patients described from previous cycles were included and grouped into two: group I consisted of 24 patients in 24 cycles in which leuprolide acetate (40 microg s.c. per day) was initiated on cycle day 2 followed by exogenous gonadotrophins on cycle day 3; group II consisted of 24 patients in 24 cycles in which ovarian stimulation included gonadotrophin-releasing hormone (GnRH) antagonist (cetrorelix, 0.25 mg daily during late follicular phase) administration. While only the oestradiol concentrations on the day of HCG were lower in group II compared with group I, the clinical pregnancy and implantation rates among groups did not show any significance. The impact of these two regimens in ovarian stimulation of poor responders seem to be same and to establish these results further randomized studies with larger sample sizes are required.

Adult↗