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PubMed1997

Protocol for the examination of specimens from patients with carcinoma of the ampulla of Vater: a basis for checklists. Cancer Committee, College of American Pathologists.

A protocol for the pathologic examination and reporting of specimens from patients with carcinoma of the ampulla of Vater has been developed by the Cancer Committee of the College of American Pathologists. The protocol incorporates all basic pathology data of diagnostic and prognostic significance appropriate for the treatment of patients with ampullary carcinoma. The purposes of the protocol are to serve as a basis for the development of checklists, as an outline for full narrative reporting, as a basis for research protocols, or as a guide for other types of synoptic or reporting formats. The protocol is stratified to accommodate the surgical procedures usually employed for carcinomas of the ampulla of Vater, including acquisition of cytologic specimens, incisional biopsy, excisional biopsy, and Whipple procedure (pancreaticoduodenectomy, partial or complete, with or without partial gastrectomy). Explanatory notes detailing specific procedures and rationales for documentation of specific pathologic data are included in the protocol. The protocol uses the staging system for carcinoma of the ampulla of Vater defined by the American Joint Committee on Cancer and the International Union Against Cancer.

Ampulla of Vater↗

PubMed1997

Updated protocol for the examination of specimens removed from patients with colorectal carcinoma. A basis for checklists.

The Cancer Committee of the College of American Pathologists has updated and expanded their protocol for the pathologic examination and reporting of specimens from patients with colorectal carcinoma, which was originally developed in 1989. The updated protocol incorporates all basic pathology data of diagnostic and prognostic significance appropriate for the treatment of patients with colorectal carcinoma. The purpose of the protocol is to serve as a basis for the development of checklists, as an outline for full narrative reporting, as a basis for research protocols, or as a guide for other types of synoptic or reporting formats. The protocol is stratified to accommodate the surgical procedures usually employed for colorectal carcinomas, including incisional endoscopic biopsy, polypectomy, local excision (transanal disc excision), and colon/colorectal resection (eg, segmental resection, total colectomy, abdominoperoneal resection). Explanatory notes detailing specific procedures and rationales for documentation of specific pathologic data are included in the protocol. The protocol uses the recently revised TNM staging system for colorectal carcinoma defined by the American Joint Committee on Cancer and the International Union Against Cancer.

Adenocarcinoma↗

PubMed1998

Developing and gaining acceptance for patient care protocols.

The purpose of developing protocols and guidelines is greater than reducing variation in practice. The process also creates new paradigms and changes the culture in which health care is delivered. The protocol itself is designed to be transient. The new environment and perceptions of how to improve health care in the future, along with new relationships and processes to accomplish this, are the real power of learning to develop and implement protocols and guidelines. Framing the process of protocol development, therefore, is more important than the resulting document. In developing protocols, attention to changing the thinking and practice of the front-line practitioners, establishing new relationships, and devising new methods of delivering and improving care is key. The process of developing protocols should include all practitioners. They should remain in control of patient care using new methods that allow: a) the monitoring of process and outcomes, b) identification of problems, and c) the evaluation and validation of the effectiveness of implemented change. Evidence from the literature of strategies for protocol development and implementation which are effective in creating change are reviewed, and an example of a known effective method which improves practice is given.

Clinical Protocols↗

PubMed2000

Effect of a moderate intensity exercise training protocol on the metabolism of macrophages and lymphocytes of tumour-bearing rats.

It is commonly accepted that moderate intensity exercise is beneficial to the immune system. We tested the influence of a moderate intensity training protocol (8 weeks) upon immune system function in Wistar tumour-bearing (TB) rats. The metabolism of glucose and glutamine in lymphocytes and macrophages was assessed, together with some functional parameters (hydrogen peroxide production and lymphocyte proliferative response). These substrates were chosen since they represent the most important energetic and synthetic metabolites for these cellular types. The training protocol caused a decrease of 17.4 per cent in the production of H(2)O(2) by macrophages, as well as a decrease in glucose consumption (25 per cent) and lactate production (47.1 per cent), and an increase in the production of labelled CO(2) from the oxidation of [U-(14)C]-glucose, in TB rats. The training protocol was also able to induce changes in the maximal activity of some key enzymes in the metabolism of glucose and glutamine, a reduction of hexokinase (68.8 per cent) activity and an increase in the activity of citrate synthase (10.1 per cent) in TB rats. The training protocol increased the proliferative response of lymphocytes cultivated in the absence of mitogens (75 per cent), of those cultivated in the presence of ConA (38.2 per cent) and in the presence of LPS (45.0 per cent). These cells also showed an increase in the maximal activity of some key enzymes of the glycolytic and glutaminolytic pathways. Our data demonstrated that the training protocol was able to induce an increase in aerobic utilisation of both substrates in lymphocytes and macrophages. The training protocol was also able to prevent several changes in glucose and glutamine metabolism that are normally present in sedentary TB rats. These changes in immune cell metabolism induced by the training protocol were able to increase TB rat survival.

Animals↗

PubMed1995

Are we all of one mind? Clinicians' and patients' opinions regarding the development of a service protocol for predictive testing for Huntington disease. Canadian Collaborative Study for Predictive Testing for Huntington Disease.

There are currently different research programs in place to assess the effects of predictive testing for a few late-onset disorders, including Huntington disease (HD) and familial cancers. Prior to providing predictive testing as a service, we sought the views of both the patients and the clinicians as to the importance and value of different items in a research protocol for HD. We mailed questionnaires to 41 clinicians and 351 at-risk patients who had participated in the research protocol, to solicit their opinions on the relative importance of various components of the HD predictive testing research protocol. Completed questionnaires were received from 256 patients (73%) and 33 clinicians (80%). Most participants (96%) were satisfied with the program, and < 3% of persons receiving a modification of risk felt that predictive testing had impaired their quality of life. While there was consensus on the importance of most components of the protocol, significantly more clinicians than patients (97% vs. 72%; P = 0.02) felt it was essential to keep written material about HD as part of a service protocol. More patients than clinicians (83% vs. 27%) considered it essential to have 24-hr contact numbers following disclosure of test results (P < 0.0001). Patients also felt more strongly about the importance of counseling about technical aspects of predictive testing (84% vs. 77%; P < 0.02), and about having a support person attend counselling sessions with the patient (62% vs. 48%; P = 0.04). Nearly 25% of participants indicated that they would not want their general practitioner routinely involved in the predictive testing program. These findings have influenced the development of our service protocol, and they underscore the importance of involving both providers and consumers of predictive testing in the development of a service protocol for genetic testing.

Adolescent↗

PubMed2003

Flow rate calibration II: a clinical evaluation study using PanLeucoGating as a single-platform protocol.

BACKGROUND: CD4(+) T-lymphocyte enumeration is vital for monitoring disease progression in individuals positive for the human immunodeficiency virus (HIV), and as a result, there is a need to develop cost-effective protocols that provide accuracy, precision, and affordability. Recently, PanLeucoGating has been shown to fulfill these requirements; however, although comparable to state-of-the-art single-platform protocols (SP), there is still a requirement for an accurate total white cell count. To overcome this limitation, we recently developed a flow-rate based calibration method that enables the PanLeucoGating protocol to be used as a SP approach, and in this study show that this approach can be used for CD4(+) T-lymphocyte enumeration. METHODS: A total of 113 HIV samples were analyzed using three protocols: (a) state-of-the art SP bead-based method (MultiSet; predicate protocol), (b) PanLeucoGating protocol used as a dual-platform (DP) approach, and (c) the newly developed flow rate-based SP approach. We demonstrate that flow rate calibration can be achieved easily and that the method is highly comparable to the state-of-the-art SP method. RESULTS: A high correlation was observed between the predicate protocol and the SP PanLeucoGating approach over the whole range of CD4 counts tested (r(2) = 0.9928; bias 8 cells/microl), including the clinically relevant range (e.g., 0-200 CD4 cells/microl; bias 0 cells/microl). For batched samples, the cost of providing a CD4(+) T-lymphocyte count was reduced to approximately US $1. CONCLUSIONS: The SP PanLeucoGating is a cost-effective approach to CD4(+) T-lymphocyte enumeration that maintains accuracy and precision.

Animals↗

PubMed2006

Low cost CD4 enumeration using generic monoclonal antibody reagents and a two-color user-defined MultiSET protocol.

BACKGROUND: The standard three-tube, three-color flow cytometric method utilizing the TriTEST reagents in conjunction with the MultiSET software commonly used in most laboratories in Thailand for CD4 enumeration is expensive and thus unavailable to most HIV-infected patients. A more affordable method, i.e., the PanLeucogating protocol using only two monoclonal antibody reagents, has been described but requires the use of the CellQUEST software that does not have automatic gating and reporting facilities. We describe a simple protocol that utilizes a two-color user-defined protocol with the automated MultiSET software for the acquisition, analysis, and reporting of CD4 results. METHODS: A two-color user-defined protocol was set up following instructions in the Becton Dickinson Biosciences MultiSET manual, adhering strictly to the information regarding the Gate and Attractor Hierarchy for analyzing various reagent combinations. This simple two-color user-defined MultiSET software was evaluated using generic monoclonal reagents in comparison with the standard TriTEST/MultiSET protocol. RESULTS: The two-color user-defined MultiSET software is easy to use. It requires only modification of the original MultiSET program and the results obtained are comparable with those derived from the standard TriTEST/MultiSET protocol. CONCLUSION: The use of this easy and reliable two-color user-defined MultiSET protocol represents an affordable alternative to CD4 testing in resource-poor settings.

Antibodies, Monoclonal↗

PubMed2005

Optimization of a blood pool contrast agent injection protocol for MR angiography.

PURPOSE: To design an ideal first-pass profile for MR angiography (MRA) by optimizing a multiphasic injection protocol based on two experimental animal models. MATERIALS AND METHODS: An equivalent contrast-enhanced (CE) MRA injection protocol was developed with controlled injection modalities (injection rate, volume, and dose) in rabbits and pigs. P792, a blood pool contrast agent, was injected in 17 male New Zealand rabbits and five farm pigs with variable injection schemes (mono- and multiphasic). From the gadolinium (Gd) blood concentration data, a simulation of an MR acquisition was performed to evaluate the impact of such an injection protocol on MR arterial signal and to select the best injection protocol. RESULTS: An empirical relationship between the arterial peak concentration and the injection parameters was found in the rabbits and pigs, allowing precise prediction of the first-pass profile. Of the four injection scheme strategies tested (standard bolus and bi-, tri-, and multiphasic injection protocols), the multiphasic "ramp" injection protocol provided the most optimal contrast agent pharmacokinetics with a durable plateau of concentration. CONCLUSION: Ramp injection protocol provides an optimized first-pass profile for CE-MRA.

Animals↗

PubMed1989

Follicular fluid steroid content and in vitro steroid secretion by granulosa-lutein cells from individual follicles among different stimulation protocols for in vitro fertilization-embryo transfer.

The in vitro steroidogenic capacity of granulosa-lutein (G-L) cells aspirated from individual follicles during cycles of in vitro fertilization-embryo transfer was examined and compared among three different stimulation protocols: human menopausal gonadotropins (hMG), clomiphene citrate (CC) and hMG, and follicle stimulating hormone (FSH). In addition, the clinical outcome of the patients in each protocol was examined. After 3 days of culture in basal medium, fresh medium with or without androstenedione (A) (10(-7) M) was added for 24 hr, at which time medium was obtained for measurement of progesterone (P) and estradiol (E) content. Follicular fluid (FF) P, E, and A were measured in each follicle and compared among protocols. FF from individual follicles in patients stimulated with FSH contained higher levels of P compared to FF from patients stimulated with hMG or CC/hMG, while E was higher in patients stimulated with CC/hMG compared to FSH or hMG. FF levels of A were not significantly different among the protocols. In vitro steroid secretion revealed a progressive increase in P secretion in contrast to decreasing E secretion when one compares CC/hMG, hMG, and FSH. Patients undergoing ovarian hyperstimulation with FSH had significantly more atretic oocytes identified at the time of oocyte harvest compared to patients undergoing ovarian hyperstimulation with CC/hMG or hMG. The hMG protocol yielded significantly fewer fertilized oocytes, cleaved embryos, and transferred embryos, compared to the CC/hMG and FSH protocol, however, there was no significant difference in pregnancy rate among the three protocols. These data demonstrate that individual follicles contain G-L cells with markedly different abilities to luteinize in vitro as assessed by steroid secretion.(ABSTRACT TRUNCATED AT 250 WORDS)

Androstenedione↗

PubMed2004

A hierarchical architecture of centralized monitoring and controlling system and its high-performance and interoperability protocol.

This paper describes a hierarchical architecture and a high-performance and interoperability protocol for centralized monitoring and controlling systems (CMCS). The protocol we proposed can interoperate different monitoring and controlling systems constructed by different companies, each with different functions and communication protocols. The protocol reduces the amount of traffic and has real-time and high-performance advantages. The protocol was implemented in CMCS for telecommunication power supply and air-conditioner used by the Telecommunication Bureau of Zhejiang Province. This paper deals with the hierarchical architecture and function of CMCS and packet format, command ID, and SDL description of its protocol. We also discuss the properties of the interoperability and performance of the protocol in this paper.

Algorithms↗

PubMed2002

Comparison of short and long ovulation induction protocols used in ART applications according to the ovarian response and outcome of pregnancy.

This retrospective study was designed to determine whether there is any difference between short and long protocol ovulation induction with Gonadotropin Releasing Hormone agonist (GnRHa) and gonadotropins used in Assisted Reproductive Technology (ART) applications according to the number of retrieved oocytes, oocyte maturity, fertilization rates, embryo quality and the outcome of pregnancies. 240 cycles consisting of in vitro fertilization (IVF) cycles without andrologic factor and intracytoplasmic sperm injection (ICSI) cycles were evaluated. 112 cycles which were induced by short protocol GnRHa and Follicle Stimulating Hormone (FSH) + Human Menopausal Gonadotropin (HMG) combinations and 128 cycles which were induced by long protocol GnRHa and FSH + HMG combinations were compared according to the number of retrieved oocytes, cancellation rate of cycles, oocyte maturity, fertilization rates, embryo quality and pregnancy rates. The cancellation rate for short protocol cycles were found to be significantly higher than those with long protocol. The number of retrieved oocytes, mature oocytes and fertilized oocytes were also found significantly lower. The quality of embryos did not show any significant difference between these groups. The clinical pregnancy rates were evidently found to be high in the long protocol cycles. As a conclusion we have found that while the number of retrieved oocytes, mature oocytes, fertilized oocytes and clinical pregnancy rates were increasing, the cancellation rate of cycles were decreasing significantly in ART cycles induced by long protocol.

Cell Count↗

PubMed2001

Harmonized protocol and certified reference material for the determination of extractable contents of phosphorus in freshwater sediments--a synthesis of recent works.

An analytical protocol for the determination of the extractable phosphorus contents in freshwater sediments has been harmonized through interlaboratory studies in the frame of the Standards Measurements and Testing Program of the European Commission. A homogeneous and stable sediment reference material has been prepared and certified on the basis of this protocol named SMT protocol, and will be available in spring of 2001. The SMT protocol, together with the reference material, are useful tools in the field of water management, especially at a time when quality assurance and data comparability are of paramount importance in laboratory analysis. The knowledge of the bioavailable forms of phosphorus is important not only for sediments but also for sludge and soils. Therefore, the SMT protocol could be extended to these materials and new CRMs could be prepared. The SMT protocol was used in a study of a reservoir, which allowed to calculate the P stock, therefore helping to predict the restoration delay of the lake. The paper describes the protocol and the CRM, and gives a brief outline of the case study.

Chemistry Techniques, Analytical↗

PubMed2005

Short tau inversion recovery and proton density-weighted fat suppressed sequences for the evaluation of osteoarthritis of the knee with a 1.0 T dedicated extremity MRI: development of a time-efficient sequence protocol.

Aim of this study was to develop a time-efficient sequence protocol for a 1.0 T dedicated MR system to be used for whole-organ scoring of osteoarthritis (OA). Thirty-four knees were examined using a protocol that included fat suppressed fast spin echo proton density weighted sequences (PDFS) in three planes plus a coronal STIR sequence. Two radiologists scored each knee by consensus for five OA features. In separate sessions, all knees were scored using three different combinations of sequences: (1) all four sequences (reference protocol, 16 min 31 s scanning time), (2) three PDFS sequences without STIR ("No STIR", 12 min 25 s scanning time) and (3) sagittal and axial PDFS sequences plus a coronal STIR sequence ("No PDFS", 11 min 49 s scanning time). Agreement of the readings using both subsets of sequences compared to the reference protocol was evaluated using weighted kappa statistics. kappa-coefficients showed good or excellent agreement for both sequence subsets in comparison to the reference protocol for all assessed features. kappa-coefficients for No PDFS/No STIR: bone marrow abnormalities (0.74/0.67), subarticular cysts (0.84/0.63), marginal osteophytes (0.77/0.71), menisci (0.75/0.79), tibial cartilage (0.71/0.78). Optimization of sequence protocols consisting of three sequences results in time savings and cost efficiency in imaging of knee OA without loss of information over a more time consuming protocol.

Female↗

PubMed2001

A modified protocol to improve the detection of enhancing brain and spinal cord lesions in multiple sclerosis.

By detecting focal blood-brain barrier (BBB) breakdown, gadolinium (Gd-DTPA) contrast-enhanced T1-weighted magnetic resonance imaging (MRI) allows assessment of inflammatory activity in multiple sclerosis (MS) and provides a sensitive means of monitoring immunomodulatory therapies in exploratory trials. Serial monthly studies were performed in eight relapsing-remitting and eight secondary progressive patients to assess new and more sensitive techniques for enhanced MRI. Brain and spine imaging was carried out at 1.5-T on two occasions 24-72 h apart using a conventional imaging protocol with T1-weighted MRI at single-dose (0.1 mmol/kg) Gd-DTPA and a potentially more sensitive "modified" protocol with T1-weighted MRI at triple-dose (0.3 mmol/kg) Gd-DTPA (with addition of delay and magnetisation transfer presaturation for brain imaging). For each MRI protocol the total numbers of enhancing lesions (97 paired studies) and new enhancing lesions (81 paired studies) were assessed. The total number of enhancing lesions seen was 347/75 on conventional brain/cord MRI respectively, and 754/123 on modified brain/cord MRI. The respective numbers of new enhancing lesions were 168/40 on conventional and 276/71 on modified scans. Smaller increases were seen in the proportion of active scans using the modified protocol. Sample size calculations showed no reduction in sample sizes required for a parallel group study but a reduced sample size for crossover studies using the modified protocol; the addition of cord to brain imaging did not improve power for either trial design. A combined modified brain and cord imaging protocol markedly improves the detection of areas of focal BBB leakage in MS and may be useful in selected natural history studies. The modified brain protocol reduces sample size requirements for crossover studies but not necessarily for parallel design trials.

Adult↗

PubMed1998

Peak power and pulmonary oxygen uptake during knee extension exercise--comparisons among different incremental protocols.

Four incremental protocols of knee extension exercise of different stage durations were compared to study the effect of the protocol upon power output at the last stage (Ppeak). Previous studies of knee extension have found very different power outputs with similar ergometers and these large differences have been interpreted as being the result of the fatigue due to the durations of the protocols. The knee extension device used in previous studies was modified to avoid the action of the knee and hip flexors: the subjects pushing on a lever instead of pulling a rod. In the present study five subjects performed four incremental knee extension exercises which differed with regard to stage duration (60, 90, 180 or 360 s) on this ergometer. The Ppeak, peak oxygen uptake (VO2peak) and peak heart rate (HRpeak) were measured at the end of each of these four incremental protocols. In eight subjects, the reliability of the protocols with the two shortest increments (60 and 90-s stages) was verified by measuring Ppeak at 60 s and 90 s (Ppeak60, Ppeak90) twice. The knee ergometer proposed in the present paper was easy to use without any special training and should improve the measurement of Ppeak. The Ppeak60 [49.4 (SD 5.6) W] was higher than at 180 s [Ppeak180), 43.6 (SD 5.8) W, P < 0.05] and at 360 s [Ppeak360, 43.4 (SD 5.3) W, P < 0.05]. All the other differences in Ppeak, VO2 peak and HRpeak were not significant. All correlations between Ppeak60, Ppeak90, Ppeak180 and Ppeak360 were significant, except those between Ppeak360 and Ppeak90 or Ppeak180. The effect of the stage duration on power output and oxygen uptake at the end of the knee extension exercises was not great. Consequently, the large differences in power output and oxygen uptake observed in previous studies cannot be explained by the protocol only. The significant difference between Ppeak 60 and Ppeak90 was of the order of 10% in agreement with findings in the literature using cycle ergometry. The reliability of Ppeak60 and Ppeak90 was high and the use of these protocols can be recommended if further studies show that the measurement of Ppeak, is useful in the evaluation of local endurance.

Adult↗

PubMed2002

Microleakage in class II composite resin restorations: application of a clearing protocol.

Microleakage at the cervical tooth/restoration interface of class II restorations was evaluated, either on multiple sections or on teeth rendered transparent, in order to determine whether a modified clearing protocol could be established as a routine method for microleakage evaluation in class II restorations. Forty-eight class II cavities were restored with a composite/bonding agent (Tetric Universal/Heliobond, Vivadent, Schaan, Liechtenstein) in bulk technique (BT) (n=24) and with a composite/dentin adhesive system (Tetric Universal/Heliobond/Syntac Classic) in increments (IT) (n=24). The 24 specimens were assigned to two groups. Group I: dye penetration (India ink), multiple sectioning (conventional method). Group II: dye penetration (India ink) and modified clearing protocol. Linear microleakage (% dye/section) along the cervical tooth/restoration interface on multiple sections, and microleakage patterns (% dye/surface) at the cervical surface on transparent teeth were evaluated with an image analyzing system. The data were statistically analyzed with the Mann Whitney U-test, Wilcoxon's rank sum test, and the error rates method. The application of the modified clearing protocol allowed for distinct evaluation of microleakage patterns. Either protocol revealed lower penetration values for IT than for BT. With the conventional protocol, the median (25-75% percentiles) percentage of dye penetration was 2% (1-46%) for IT and 40% (23-85%) for BT. The clearing protocol revealed dye penetration of 5% (1-22%) for IT and 16% (4-24%) for BT. The clearing protocol together with the use of India ink as tracer allows for evaluation and visualization of the continuous distribution of microleakage at the cervical tooth/restoration interface without loss of information due to sectioning, although this method seems to be less discriminative than the conventional sectioning technique.

Acrylates↗

PubMedDate not supplied

Pediatric germ cell tumors: protocol update for pathologists.

The therapy for pediatric germ cell tumors has historically been widely variable and institution dependent. The efforts to provide consistent, biology-driven therapy through Intergroup protocols has been a relatively recent phenomenon that has provided the framework for future protocol designs. The first Intergroup protocols confirmed that stage I malignant testicular germ cell tumors and immature teratomas at all sites in children could be treated with surgery alone followed by close observation. Future protocols currently in the planning stages may extend this low-risk category to stage I ovarian germ cell tumors of all histologic types. Low-stage extragonadal germ cell tumors may be placed in a new intermediate risk category. Particular pathologic issues that were raised and reported during the first protocols and that may impact on future protocol design include the presence and size of foci of endodermal sinus tumors within low-stage immature teratomas at all sites. Accurate staging will grow more critical in future protocols. The ability to recruit international cooperative groups will determine the success of chemotherapy tailored to specific subgroups that now must be lumped for statistical purposes. Lastly, companion biologic studies will be critical to defining the different subtypes of germ cell tumors and to determining predictors of biologic behavior.

Adolescent↗

PubMed2006

Efficacy of low-dose human chorionic gonadotropin (hCG) in a GnRH antagonist protocol.

PURPOSE: To examine the efficacy of low-dose hCG using a GnRH antagonist protocol. METHODS: Prospective randomized study was performed at the Kyono Ladies Clinic. One hundred ninety-two women (<40 -years old, <3 previous cycles) were randomly assigned to GnRH agonist (buserelin) long protocol (LP, n = 66), GnRH antagonist (cetrorelix) with no low-dose hCG protocol (NhCGP, n = 63), or GnRH antagonist with low-dose hCG protocol (hCGP, n = 63). RESULTS: The hCGP was associated with reduced total amounts of FSH, increased oocyte maturation rate, high-quality day 3 embryos rate, and number of frozen embryos. Ovarian hyperstimulation syndrome (OHSS) tended to be lower in the GnRH antagonist protocol. Pregnancy and implantation rates did not differ significantly between study groups. CONCLUSIONS: Daily low-dose hCG supplementation in the late follicular phase could improve the outcome in FSH based-GnRH antagonist protocol. This protocol, however, does require further modifications, including determination of the optimal doses for hCG and gonadotropin pretreatment.

Adult↗