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Improved outcome of coronary stenting by utilizing a modified treatment protocol.

Coronary stents improve patient outcome, are easy to deploy and are now being utilized very frequently after coronary angioplasty. New protocols have been suggested to overcome the main limitations of stenting, namely subacute stent thrombosis, local vascular complications, and the length of hospitalization. In this report we describe our current results with coronary stenting in 100 patients: we modified our standard protocol and used high pressure noncompliant balloons to expand the stent, added ticlopidine to some of the patients to inhibit platelet activity, and used the transradial approach in some patients to reduce the risk of vascular complications. These results were compared to those obtained in our initial group of 50 patients in whom we used a standard implantation protocol. Subacute thrombosis occurred in one patient in the current group of patients compared to five patients in our early experience (P = 0.026). There was no change in local vascular complications. This preliminary report shows that subacute thrombosis can almost be eliminated by the new stent implantation protocols. Less aggressive anticoagulation and radial artery catheterization can decrease vascular complications.

Aged↗

[Ovarian stimulation using a protocol of low dose agonist in patients with an elevated basal FSH].

This study compare the ovarian response of patients with high day 3 FSH (> 6.5 UI/L), treated with two protocols; a protocol with a low dose of GnRH agonist and a so called "long protocol" with GnRH agonist in a depot formula. The ovarian response with the agonist low dose was better with less ampules (37.1 vs 46.6) and a shorter duration of stimulation (10.5 vs 12.4 days). The number of mature oocyte was higher (5.9 vs 4.5) as well as the number of good quality embryo (3.2 versus 2.3). The E2 levels on day 8 was higher (1065 vs 460 pg/ml). The cancellation rate was lower (14% vs 26%). The use of the low dose protocol gave a better ovarian response for patients with high 3 FSH. Large randomized studies are needed to confirm these data.

Adult↗

Implementing therapist-driven protocols.

In January of 1993, as part of a hospital-wide cost-reduction strategy, the University of California San Diego (UCSD) Medical Center Respiratory Care Department implemented a patient-driven protocol program designed to utilize the assessment skills and judgments of respiratory care staff, within physician-approved guidelines. This program produced a 60% reduction in the use of hand-held nebulizer therapy and chest physical therapy in the institution, with a substantial decrease in operational expenses. This article describes key elements of the implementation of protocol-driven programs, provides examples from the UCSD experience, and offers insights gained from others who have been successful agents of change. It describes patient-driven protocols, how they can be implemented, the barriers to and promoters of such protocols, and what the results can be for a respiratory care department.

Clinical Protocols↗

Therapist-driven protocols for pediatric patients.

Most therapist-driven respiratory care protocols deal with adult care. The greatest difficulty we have encountered when implementing pediatric protocols involves patient assessment. We have found that with any protocol the key factor is to monitor closely the result of the treatment and to analyze that outcome and compare it with the purpose of the therapy. When careful clinical assessments are accomplished, pediatric protocols can be established.

Adolescent↗

Developing an anemia management protocol. Case study of the anemic patient.

Anemia is best managed with an effective protocol that provides standardized guidance for clinical interventions while maintaining the flexibility to respond to the needs of individual patients. An anemia management protocol can help nurses and other clinicians: (a) monitor and manage erythropoietic parameters, (b) successfully achieve the higher hematocrit (33% to 36%) and hemoglobin (11 g/dL to 12 g/dL) target levels recommended by the Dialysis Outcomes Quality Initiative (DOQI) guidelines, and (c) maintain a stable Hct to help manage the new Medicare Hematocrit Measurement Audit policy. Maintaining a stable hematocrit higher in the target range has been associated with improved patient outcomes. This article describes how to use a continuous quality improvement (CQI) approach to develop an anemia management protocol. The potential benefits of coordinating protocol implementation through an anemia management nurse are also discussed.

Anemia↗

Rapid infusion of streptokinase standard dose in acute myocardial infarction is followed by a higher rate of coronary reperfusion than standard protocol.

There are several opinions asserting that the accelerated t-PA is more efficient than the standard protocol of streptokinase (SK) administration in acute myocardial infarction (AMI). One hundred patients admitted within the first 6 hrs after the onset of the symptoms revealing AMI were divided in two subgroups, as follows: subgroup A (50 patients) in whom a dose of 1.5 M.U. SK was infused in 20 min (accelerated protocol) and subgroup B (50 patients) in whom the same dose was infused in 60 min (standard protocol). In order to assess the efficiency of thrombolytic therapy (TT), we used three noninvasive criteria: the rapid resolution of the chest pain, the rapid decreasing of the ST segment elevation by more than 50% from the initial value, and the rapid increasing of enzymes revealing necrosis. Using the above-mentioned criteria, we considered that coronary reperfusion appeared in 40 patients from subgroup A (80%) and in 29 patients from subgroup B (58%). The speed of coronary reperfusion was 40 +/- 26 min in patients with accelerated SK and this time was significantly shorter than the time of 60 +/- 24 min registered in the control group. No major hemorrhagic events appeared in both subgroups. Although hypotension appeared more frequently in subgroup A, this minor complication was well supported by our patients. The rapid infusion of the standard dose of SK was followed by a higher rate and speed of coronary reperfusion as compared to the standard protocol.

Aged↗

["Step protocols"].

Within the last decade, induction of ovulation with gonadotrophins, specially for patients with polycystic ovary syndrome, has been extensively revisited. On the basis of physiological concepts as the FSH threshold, the FSH window and the hypersensitivity to FSH of selected dominant follicle, news protocols have been described: step-up protocol, step-down, sequential protocol. In this article, their efficacy and safety are discussed. It is presumed that these new protocols would open a new way in the management of ovulation induction.

Clinical Protocols↗

How to design an anemia management protocol.

An anemia management protocol ensures consistent treatment of anemia in end-stage renal disease (ESRD) patients by basing a treatment plan on the evaluation of hematocrit values and iron stores, the provision of safe and effective iron supplementation the systematic dosing of recombinant human erythropoietin (rHuEPO), and careful monitoring of patient' outcomes. The protocol must be designed specifically for the institution in which it will be implemented. This article outlines the steps an institution can take to develop and implement an anemia management protocol and includes a case study on how. The Centers for Dialysis Care in Cleveland. OH designed and implemented a protocol in their seven facilities.

Algorithms↗

Representing the work of medical protocols for organizational simulation.

Developing and implementing patient care protocols within a specific organizational setting requires knowledge of the protocol, the organization, and the way in which the organization does its work. Computer-based simulation tools have been used in many industries to provide managers with prospective insight into problems of work process and organization design mismatch. Many of these simulation tools are designed for well-understood routine work processes in which there are few contingent tasks. In this paper, we describe theoretic that make it possible to simulate medical protocols using an information-processing theory framework. These simulations will allow medical administrators to test different protocol and organizational designs before actually using them within a particular clinical setting.

Clinical Protocols↗

Development of an optimal protocol for antigen retrieval: a 'test battery' approach exemplified with reference to the staining of retinoblastoma protein (pRB) in formalin-fixed paraffin sections.

The retinoblastoma (RB) gene, which encodes the nuclear RB protein (pRB), is believed to be involved in cell cycle control and cell differentiation. Studies have demonstrated that loss of RB function may play a role in tumour formation and progression of a variety of human tumours, such as bladder, lung, breast, and prostate cancers. The immunohistochemical detection of pRB expression in formalin-paraffin sections of human cancer has potential advantages of convenience, economy, and compatibility with routine surgical pathology practice. In practice, however, results using pRB antibodies on routinely processed, paraffin-embedded tissue have been inconsistent. In this study, the antigen retrieval (AR) method has been applied to the immunohistochemical detection of pRB in paraffin-embedded tissues and a 'test battery' approach has been developed to identify the principal variables that result in the optimal AR protocol. This approach includes the use of buffered solutions at pH 1, 6, and 10 with three different heating conditions (temperatures 120 degrees C, 100 degrees C, and 90 degrees C). In the example described here with antibody RB-WL-1, the low pH solution with the microwave heating at 100 degrees C proved most effective. Both fresh and routinely processed formalin-paraffin tissues of normal and bladder carcinoma were used for a comparison of the pRB immunostaining. The AR method was evaluated by comparing the immunohistochemical staining result on routinely processed formalin-paraffin sections with frozen sections of the same tumour. A consistent intensity of immunohistochemical staining for pRB was achieved using the identified optimal AR protocol on formalin-paraffin sections. All slides showed positive staining of pRB in normal mesenchymal and epithelial tissues. The pattern of pRB localization and intensity of staining was similar to that obtained in frozen sections, though the intensity obtained by AR treatment on paraffin sections was slightly to moderately stronger than that obtained in frozen sections. Once the protocol was identified, it was tested using routinely processed paraffin tissue sections of 245 cases of bladder carcinoma, with consistent pRB immunostaining results. The protocol described is simple to perform and gives reproducible results for evaluation of pRB expression by immunohistochemistry.

Cryopreservation↗

Transplantation analyses of the immunogenicity of epidermal tumors generated in murine skin two-stage carcinogenesis protocols.

SSIN mice are very sensitive to tumor promoters in two-stage skin carcinogenesis protocols. It was recently reported that SSIN mice have fewer CD8+ T-cells than other strains of mice and develop a weaker cytotoxic T-cell response upon challenge with an allogeneic tumor transplant. The significance of this muted immune response to processes involved in two-stage carcinogenesis depends on the immunogenicity of the tumors generated in such protocols. Although they have low CD8+ T-cell contents, SSIN rejected a variety of subcutaneously transplanted allogeneic murine tumors. Analyses of the growth of primary papillomas derived from 7,12-dimethylbenz[a]anthracene-initiated/12-O-tetradecanoylphorbol-13-ac etate-promoted SSIN mice and then subcutaneously transplanted into triple-deficient (bg-nu-xid), athymic nude and immune-competent and immunosuppressed SSIN mice revealed that few tumors took and tumor takes were not markedly influenced by the immumological status of the transplant recipient. Two tumor cell lines (RS1 and RS2) were derived from the transplantation studies and could be passaged in normal SSIN mice (H-2q haplotype). Both tumors were squamous cell carcinomas (SCCs) by the second in vivo passage and were rejected in allogeneic mice (BALB/c) but grew in FVB/N mice, a strain having the H-2q haplotype. Transplantation studies revealed that prior exposure to RS1 and RS2 did not prime SSIN mice to reject a subsequent tumor challenge. Three primary SCC tumors derived from SSIN mice in a two-stage carcinogenesis protocol also grew when subcutaneously transplanted in SSIN mice and could be serially passaged. Consequently, the epidermal SCCs that develop in two-stage carcinogenesis protocols appear to be nonimmunogenic.

9,10-Dimethyl-1,2-benzanthracene↗

Construction of a protocol for measuring blood flow by two-dimensional phase-contrast MRA.

Our aim is to describe and demonstrate the steps we have found to be useful in the construction and evaluation of protocols for triggered and nontriggered measurement of blood flow by two-dimensional phase-contrast magnetic resonance angiography (MRA). To achieve this goal, we start with a survey of factors governing the accuracy (validity) and precision (repeatability) of MR flow measurements. This knowledge, combined with prior information regarding the diameter of the target vessel and the prevailing flow conditions, is then employed to define a protocol for measuring flow with negligible systematic error. In the absence of a gold standard for in vivo flow measurements, the protocol is subsequently validated for a range of flow conditions by representative phantom experiments. Precision is then calculated from the signal-to-noise ratio (SNR) of blood in the accompanying magnitude images or, less conveniently, estimated from the standard deviation of repeated measurements. The desired precision is finally achieved by adjusting the appropriate SNR parameters. All steps involved in protocol development are demonstrated for both flow-independent and flow-dependent acquisitions.

Artifacts↗

Detection of S cells and evaluation of DNA denaturation protocols by image cytometry of fluorescent BrdUrd labelling.

This paper addresses the problem of detecting weak incorporation of BrdUrd and the related efficiency of the denaturation protocols used to unmask this thymidine analog. Evidence is presented that measuring the distribution of BrdUrd-tagged fluorescence intensities by image cytometry generates a standard deviation threshold that discriminates between positive and negative MRC5 cells in vitro. A comparison of the thresholding by standard deviation (SDT) with the usual thresholding by the nuclear total fluorescence intensity (FIT) demonstrated that SDT has a significantly higher sensitivity (99.4-100%, depending on the denaturation protocols) than FIT (94.7 and 74.3%, respectively), although both tests have a high specificity (93% and 100%, respectively) for detecting S cells. Since detecting the S cells is not only dependent on the test used, but also on the denaturation protocols, a quality index (QI) was derived from the standard deviation and the mean value of the non-specific fluorescence of negative cell population versus BrdUrd fluorescence of positive cell population. The following DNA denaturation protocols have been assessed according to QI: acidic denaturation, thermal denaturation in formamide, and thermal denaturation in distilled water. Each denaturation procedure was preceded or not by incubation in either proteinase K or Triton X-100. The results showed that thermal denaturation in formamide, especially when preceded by proteinase K incubation, revealed the largest difference between negative and positive cells. This work also demonstrated that image cytometry of BrdUrd-labelled cells can be suitable for clinical application because of the high sensitivity provided and the small samples needed.

Bromodeoxyuridine↗

A universal and rapid protocol for protein extraction from recalcitrant plant tissues for proteomic analysis.

A simple and universally applicable protocol for extracting high-quality proteins from recalcitrant plant tissues is described. We have used the protocol with no modification, for a wide range of leaves and fruits. In all cases, this protocol allows to obtain good electrophoretic separation of proteins. As the protocol is rapid, universal, and compatible with silver staining, it could be used for routine protein extraction from recalcitrant plant tissues for proteomic analysis.

Electrophoresis, Gel, Two-Dimensional↗

Development of a standard protocol for in vitro cytogenetic testing with Chinese hamster ovary cells: comparison of results for 22 compounds in two laboratories.

A major problem of cytogenetics testing in mammalian cells is lack of agreement of results among laboratories. Our objective was to develop a sensitive in vitro test protocol that was applicable to large-scale chemical screening and yielded comparable results in two laboratories. We used sister chromatid exchange (SCE) and chromosome aberration (CAb) tests in Chinese hamster ovary (CHO) cells. The initial protocol used standard cell densities, medium, batch of rat liver S9 for metabolic activation; positive, negative, and solvent controls; staining and scoring techniques; and fixation times. Treatment without S9 was for 8-12 hr (CAb) or 26 hr (SCE), and with S9 for 2 hr in serum-free medium. Bromodeoxyuridine (BrdUrd) (10 microM) was added to SCE cultures only, 2 hr after addition of the test chemical. Doses were based on the 50% toxicity level in a preliminary test of cell survival 24 hr after treatment. One hundred cells (CAb) or 50 cells (SCE) were scored from each control and from five dose levels. Five clastogens were tested in the first two-laboratory comparison: mitomycin-C, triethylenemelamine, N-methyl-N'-nitro-N-nitrosoguanidine, cyclophosphamide, and benzo(alpha)pyrene. There was quite good agreement between laboratories. Seventeen compounds were then tested "blind" in the two laboratories. As testing proceeded, some discrepancies occurred between the laboratories, and the protocol was modified in attempts to improve the resolution of marginal responses and make dose selection more consistent. The preliminary test for cell survival was omitted. A 10(5) dose range in a half-log series was tested, and cells were scored at the highest dose at which sufficient mitotic cells were obtained, and at the next two lower doses. By delaying fixation times, SCE and CAb were scored at doses that inhibited cell cycle progression. This protocol gave comparable results in the two laboratories in many cases and by testing up to a maximum dose, limited by solubility and/or toxicity, should detect a high proportion of clastogens and SCE inducers.

Animals↗

Designing standardized clinical protocols: some organizational and behavioral issues.

In the present environment, the clinical ordering patterns of hospital-based physicians can be expected to come under increasing scrutiny. This paper considers three major aspects of the case for inpatient clinical ordering protocols. First, it reviews the argument that hospitals do not, at present, exercise adequate management over physician-triggered resource consumption. Subsequently, the paper examines existing but partial protocol models in the United States and Scandinavia that could provide a basis for an adequate physician management system. In its third section, the paper explores the fundamental characteristics of a full-fledged Standardized Clinical Protocol (SCP) system, developing two alternative 'ideal-type' models for further discussion. The paper concludes with the argument that physicians, rather than economists or politicians, should control the design of future protocol systems.

Behavior↗

Real-time PCR for single-cell genotyping in sickle cell and thalassemia syndromes as a rapid, accurate, reliable, and widely applicable protocol for preimplantation genetic diagnosis.

Sickle-cell and beta-thalassemia syndromes are priority genetic diseases for prevention programs involving population screening with the option of prenatal diagnosis for carrier couples. Preimplantation genetic diagnosis (PGD) represents a specialized alternative to prenatal diagnosis and is most appropriately used for couples with an unsuccessful reproductive history and/or undergoing assisted reproduction. However, clinical application of PGD has been hindered by difficulties in reliably transferring molecular diagnostic protocols to the single-cell level. We standardized and validated a protocol involving first-round multiplex PCR, amplifying the region of the beta-globin gene containing most of the common disease mutations world-wide and two unlinked microsatellite markers (GABRB3 and D13S314), followed by: 1) analysis of beta-globin genotypes with real-time PCR and 2) microsatellite sizing to exclude chance contamination. The protocol was standardized on 100 single lymphocytes from a beta-thalassemia heterozygote, including 15 artificially contaminated samples, the latter demonstrated through microsatellite analysis. PCR failure and allele drop-out (ADO) were observed in one (uncontaminated) sample each (1.2%). A pilot study in six clinical PGD cycles with five different beta-globin genotype interactions achieved results (in 5-6 hr) in 46 out of 50 single blastomeres (92%), all concordant with results from an established PGD method applied simultaneously; microsatellite analysis detected only parental alleles, excluding contamination. Beta-globin genotypes were also confirmed in two blastomeres through prenatal diagnosis (twin pregnancy), and in 11 out of 12 spare embryos, revealing one incident of ADO. Overall, the protocol proved to be sensitive, accurate, reliable, rapid, and applicable for many genotype interactions, with internal monitoring of contamination, thus fulfilling all requirements for clinical PGD application.

Anemia, Sickle Cell↗

The effectiveness of skin care protocols for pressure ulcers.

Pressure ulcers (PU) remain a serious healthcare problem in the United States. This study investigated the effectiveness of a prevention and early intervention program in reducing the prevalence of pressure ulcers (i.e., the number or the percentage of persons with pressure ulcers at a given time) in a rehabilitation hospital. The Braden Scale for Predicting Pressure Sore Risk was used to assess subjects' PU risk. Protocols were established for PU stages consistent with the National Pressure Ulcer Advisory Panel consensus statement on pressure ulcers. Staff were educated about PUs and the specific protocols for prevention and treatment. Concurrent quarterly prevalence audits on a total of 116 patients were conducted for 1 year. An audit also was done 16 months after protocols had been established. There was a 60% decrease in pressure ulcer prevalence from the 25% baseline to the 10% found at the audit following implementation of the protocols.

Aged↗