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PubMed2005

Protocol audits for post-approval monitoring of animal use protocols.

Monitoring of animal use protocols following IACUC approval is a way to ensure regulatory compliance and to improve communication between the IACUC and investigators. The authors describe the protocol audit system used by the University of California, San Diego's Animal Welfare Program to ensure that IACUC-approved protocols are followed. This program, as well as the protocol audit form they provide, can be used by institutions to initiate, enhance, or evaluate post-approval monitoring programs.

Animal Care Committees↗

PubMed2001

A post-processing protocol for three-dimensional visualization of the inner ear using the volume-rendering technique based on a standard magnetic resonance imaging protocol.

A superior diagnostic quality compared to other post-processing (PP) techniques for three-dimensional (3D) inner ear imaging has been attributed to volume rendering (VR). We defined and assessed a VR protocol for 3D visualization of the inner ear in a routine imaging setting. Following definition of a VR protocol by using lower threshold values, surface shading, perspective views and related parameters, standardized 3D views of the inner ear were generated and evaluated in 32 patients suffering from sensorineural or combined hearing loss. Comprehensive inner ear visualization was achieved in 28 patients by means of two 3D shaded-surface views. Incomplete data acquisition (1/32), motion and pulsation artefacts (2/32) and interposed fluid-retaining mastoid cells (1/32) were responsible for non-diagnostic image quality in 4/32 patients. In 5/32 patients modifications of the PP protocol involving the threshold value and depth-cueing parameters helped to establish diagnostic image quality. Mean post-processing time amounted to 5.8 min per site. 3D imaging with the VR technique is suitable for routine inner ear assessment if direct VR, predefined PP protocols and standardized labyrinthine views are used.

Artifacts↗

PubMed1999

Comparison of an age adjusted warfarin loading protocol with empirical dosing and Fennerty's protocol.

AIM: A warfarin loading protocol adjusting doses for age was compared to both Fennerty's protocol (Fenn) and empirical dosing (Emp). METHODS: Patients beginning warfarin were randomised to receive doses according to either the age adjusted (Age) protocol or Fenn. Data were retrospectively collected for patients who had begun warfarin in the previous six months to represent empirical dosing. The study was performed on inpatients being commenced on warfarin for the first time at two teaching hospitals. MAIN OUTCOME MEASURES: Endpoints were time to reach a stable, therapeutic International Normalised Ratio (INR) between 2-3, the number of patients experiencing an INR > or =4 in the first week and the number of patients who had a dose held in the first week. RESULTS: Thirty-five patients were assessed in the Age group, 28 in the Fenn group, and 123 patients for the Emp group. Patients using the Age protocol achieved a stable, therapeutic INR more rapidly than either the Fenn (p=0.003, log rank test) or Emp (p<0.001) group. The Age group had a lower proportion of patients experiencing an INR > or =4 in the first week (p<0.05) as well as a lower proportion having doses held in the first week (p<0.01). There were no differences between Emp and Fenn for any of the endpoints. CONCLUSION: Adjustment of warfarin loading doses for age exhibits clear superiority over the use of Fenn or Emp. This becomes increasingly important as the average age of patients being warfarinised increases, with the recognition that atrial fibrillation requires anticoagulation. Fenn consistently overdosed elderly patients, especially those aged 80 years and older.

Age Factors↗

PubMed2006

The effects of beta-blockers on dobutamine-atropine stress echocardiography: early protocol versus standard protocol.

BACKGROUND: To study the effects of Beta-blockers during Dobutamine Stress Echocardiography (DSE) comparing the hemodynamic benefits of an early administration of atropine in patients taking or not Beta-blockers. METHODS: One hundred and twenty-one patients were submitted to dobutamine stress echocardiography for the investigation of myocardial ischemia. The administration of atropine was randomized into two groups: A or B (early protocol when atropine was administered at 10 and 20 mcg/kg/min of dobutamine, respectively) and C (standard protocol with atropine at 40 mcg/kg/min of dobutamine). Analysis of the effects of Beta-blockers was done regarding the behavior pattern of heart rate and blood pressure, test time, number of conclusive and inconclusive (negative sub-maximum test) results, total doses of atropine and dobutamine, and general complications. RESULTS: Beta-blocked patients who received early atropine (Group A&B) had a significantly lower double product (p = 0.008), a higher mean test time (p = 0.010) and required a higher dose of atropine (p = 0.0005) when compared to the patients in this group who were not Beta-blocked. The same findings occurred in the standard protocol (Group C), however the early administration of atropine reduced test time both in the presence and absence of this therapy (p = 0.0001). The patients with Beta-blockers in Group A&B had a lower rate of inconclusive tests (26%) compared to those in Group C (40%). Complications were similar in both groups. CONCLUSION: The chronotropic response during dobutamine stress echocardiography was significantly reduced with the use of Beta-blockers. The early administration of atropine optimized the hemodynamic response, reduced test time in patients with or without Beta-blockers and reduced the number of inconclusive tests in the early protocol.

Adrenergic beta-Antagonists↗

PubMedDate not supplied

[Sclerotherapy of the internal saphenous vein: comparison between the trombovar protocol and the trombovar-iodine protocol].

Sclérosing injections of the long saphenous vein involve different protocols concerning technique as well as the sclerosing fluids and doses used. This retrospective study involved comparison of two groups of patients treated during successive periods on the basis of a protocol consisting of 3 per cent Trombovar at doses increasing progressively up to a maximum of 6 and another protocole as follows: 3 per cent Trombovar, 1 ml; 3 per cent Trombovar 2 ml; 8 per cent Variglobine 2 ml; 12% Variglobine 2 ml; 12 per cent Variglobine 3 ml; "Overdose" (12 per cent Variglobine 6 ml + 3 per cent Trombovar 6 ml, i.e. 2-4 ml as divided doses. Patients were seen for follow-up evaluation by continuous wave Doppler after six months and two years. The first protocole, with a mean follow-up of 11.5 months, was associated with a 40 per cent recurrence rate. The rate for the second, with a mean follow-up of 13.5 months, was 15.87 per cent. The difference between these figures was statistically very significant (p approximately 0.001). The largest amounts of sclerosing fluid provided lower percentage recurrence rates compared relatively small amounts.

Benzyl Alcohols↗

PubMed2005

The F + 0 protocol for diuretic renography results in fewer interrupted studies due to voiding than the F - 15 protocol.

UNLABELLED: Timing of diuretic administration is not universally standardized in renography. Over the past year, our practice has changed from F-15 administration of furosemide to an F + 0 protocol. Therefore, we have retrospectively compared these 2 cohorts to assess if the shorter interval between diuretic administration and study completion in the F + 0 study results in a greater frequency of patients able to complete the subsequent 30-min dynamic acquisition without disruption due to voiding. METHODS: We identified 108 diuretic (99m)Tc-mercaptoacetyltriglycine renograms performed in the previous 18-mo period. Three patients were given furosemide at 30 min after the radiopharmaceutical and were excluded. Twenty studies in children under 3 y of age were excluded from consideration because voiding is neither restricted in this age group nor does voiding into a diaper cause disruption. Forty milligrams of furosemide were administered to adults, whereas 0.5 mg/kg was given to children. In the first cohort of 56 studies, radiopharmaceutical was administered 15 min after furosemide (F-15), whereas, in the second cohort of 29 patients, it was administered immediately thereafter (F + 0). In all cases, patients were asked to void proximal to radiopharmaceutical injection. Dynamic images and renogram curves were inspected for evidence of interruption or voiding midstudy. Statistical significance was determined by a 1-tailed Fisher exact test for proportions, with P < 0.05. RESULTS: The F-15 and F+0 groups of patients were comparable in terms of age, sex, and diuretic amount. In 17 of the F-15 patients, renography was interrupted because of voiding (30%), whereas this occurred in only 3 of the F + 0 patients (10%). This difference was significant at the P = 0.033 level. The mean time of voiding was 18.3 min (range, 12-25 min) for F-15 patients and 16 min (range, 12-19 min) for the F + 0 group. CONCLUSION: The F + 0 renal diuretic protocol is associated with a significantly lower rate of disruption because of voiding than the F-15 protocol, likely due to the shorter period between diuretic administration and study termination, which results in less bladder distention and discomfort. On the basis of these data, the F + 0 protocol appears to be a more tolerable procedure.

Adolescent↗

PubMed1979

Development and field testing of protocols for the management of pediatric telephone calls: protocols for pediatric telephone calls.

Although telephone calls comprise almost one fourth of all childhood patient-physician contacts, the content of telephone care is not emphasized in most educational and service programs. In response to the need to improve management of telephone calls to our pediatric emergency room, we developed 28 protocols to deal with the 25 most common complaints presented by phone. This paper describes the content of these protocols, the training of the health assistants who administered them, and the measures we took to assure their safety and general utility in pediatric practice settings. The study demonstrates the feasibility of an organized system for telephone care based on protocols which include: (1) basic data to be collected for each chief complaint category; (2) a range of appropriate dispositions; and (3) advice for home management when the patient does not require an immediate medical visit. Potential uses of these protocols for medical and nursing education and for clinical service needs are discussed.

Age Factors↗

PubMed1984

Protocols for the use of psychoactive drugs: Part III. Protocol for the treatment of bipolar affective disorder with lithium.

A step-wise protocol is described for the treatment of bipolar affective disorder, with emphasis on the use of lithium. The objective of this protocol is to delineate the steps clinicians must consider in monitoring a patient who is receiving treatment for bipolar affective illness. While not covering every aspect of treatment, the protocol does provide the basic steps necessary for care; it is intended for use in conjunction with the clinician's personal expertise. The protocol has also been found useful in the training of residents and students.

Ambulatory Care↗

PubMed1992

Results of the LMT81 protocol, a modified LSA2L2 protocol with high dose methotrexate, on 84 children with non-B-cell (lymphoblastic) lymphoma.

From May 1981 to June 1989, 84 children with non-B-cell lymphoma (82 lymphoblastic, 1 T-cell immunoblastic, 1 unclassified diffuse lymphoma) were treated in the pediatric department of the Institut Gustave Roussy according to a protocol called LMT81, which was derived from the LSA2L2 protocol of Wollner and modified by the adjunction of 10 courses of high dose methotrexate to improve the CNS prophylaxis. No planned irradiation was performed except in cases of initial tests (2 patients) or CNS (5 patients) involvement and residual mass (2 patients). Sixty patients had mediastinal involvement; for the others, primaries were in the head and neck (7), nodes (2), (sub)cutaneous (4), bone (7), and elsewhere (2). According to Murphy's staging system, there were 2 stage I, 6 stage II, 33 stage III, and 43 stage IV. Among the stage IV patients, 41 had bone marrow involvement, 24 of them with more than 25% blast cells in bone marrow and 19 with blast cells in blood; 7 had CNS involvement. Three patients did not achieve complete remission, 4 died in remission (two measles, one post-transfusion AIDS, one unexplained definitive aplasia) and 13 relapsed at 2 to 29 months (median-13 months). Among the 77 patients without initial CNS involvement, there was only one isolated CNS relapse. With a median follow-up of 57 months (10-106 months), the event-free survival is 75% (SE 2.5) for the 84 patients with a plateau at 29 months, 73% (SE 8) for stage I and II patients, 79% (SE 4) for stage III, and 72% (SE 4) for stage IV patients. Survival was similar in each stage group. Reasons for failure of treatment, however, were different, being toxic deaths in stage II; initial therapy resistance, early relapses, and toxic deaths in stage III; and tumor failures in stage IV. In conclusion, this protocol is efficacious on T and non-T, non-B childhood lymphoma with a low incidence of CNS relapse. A future study will seek to diminish toxicity and long-term sequellae while at least maintaining the same cure rate of patients.

Adolescent↗

PubMed2004

A modified gonadotropin-releasing hormone (GnRH) antagonist protocol failed to increase clinical pregnancy rates in comparison with the long GnRH protocol.

The purpose of this prospective randomized study was to compare stimulation characteristics and IVF outcomes of the standard long GnRH agonist protocol for ovarian stimulation with a modified GnRH antagonist protocol. Starting GnRH antagonist in a flexible protocol according to the size of the leading follicle, with simultaneous augmentation of 75 IU recombinant FSH, failed to increase clinical pregnancy rates.

Adult↗

PubMed1996

Short protocol of gonadotropin releasing hormone agonist administration gave better results in long protocol poor-responders in IVF-ET.

OBJECTIVE: To determine the effectiveness of a short protocol (SP) of gonadotropin-releasing hormone agonist (GnRH-a) administration in patients who already had undergone at least one in vitro fertilization (IVF) and embryo transfer (ET) treatment cycle with the long protocol (LP) and had shown poor results. METHODS: One hundred and twelve patients were studied. The E2 levels, the number of preovulatory follicles, the number of oocytes retrieved and fertilized, the number of embryos cleaved, the fertilization rate and the number of embryos transferred were calculated. RESULTS: The values for the mentioned parameters were significantly higher in the SP than those in the LP. So were the pregnancy rates per cycle and per ET (23.2% and 24.1%, respectively) in the SP significantly (p < 0.0001) higher than those in the LP (12.5% and 13.5%, respectively). CONCLUSION: In cases who showed poor results to the LP, instead of repeating the same protocol the SP may be substituted. This strategy may not only improve the results, but also decrease the total cost of the IVF-ET treatment.

Adult↗

PubMed1995

Combination chemotherapy (RCM protocol: response-oriented cyclic multidrug protocol) for the acute or lymphoma type adult T-cell leukemia.

43 patients with the acute or lymphoma type ATL were treated with the new combination chemotherapy (RCM protocol: response-oriented cyclic multidrug protocol) between January 1989 and December 1991. Complete response (CR) and partial response (PR) were achieved in 20.9% and 65.1% of all treated patients respectively. The median duration of survival was 6.0 months. The survival duration of patients with a high serum lactate dehydrogenase (LDH) value (> or = 1,000 unit) and/or a poor performance status (PS) (PS 3 or 4) were also improved but not in patients with a severe leukocytosis (> or = 35,000/microliters). Toxicity was mild (grade 1 or 2) except hematologic toxicity in 4 patients (9.3%) and alopecia in one patient (2.3%). In spite of many patients with a poor PS (PS 3 or 4), our chemotherapeutic results are equal or superior to other previous reports. It seems that response-oriented chemotherapy is suitable for the ATL patients with poor prognostic factors. These results indicate that the RCM protocol is very useful as the first choice chemotherapy for the acute or lymphoma type ATL.

Adult↗

PubMed2001

ACT-PRO action protocol analyzer: a tool for analyzing discrete action protocols.

This article presents a top-down approach for analyzing sequential events in behavioral data. Analysis of behavioral sequential data often entails identifying patterns specified by the researchers. Algorithms were developed and applied to analyze a kind of behavioral data, called discrete action protocol data. Discrete action protocols consist of discrete user actions, such as mouse clicks and keypresses. Unfortunately, the process of analyzing the huge volume of actions (typically, > 10(5)) is very labor intensive. To facilitate this process, we developed an action protocol analyzer (ACT-PRO) that provides two levels of pattern matching. Level one uses formal grammars to identify sequential patterns. Level two matches these patterns to a hierarchical structure. ACT-PRO can be used to determine how well data fit the patterns specified by an experimenter. Complementarily, it can be used to focus an experimenter's attention on data that do not fit the prespecified patterns.

Algorithms↗

PubMed2006

IGF-I and epidermal growth factor levels in follicular fluid of women undergoing controlled ovarian hyperstimulation using the multidose GnRH-antagonist protocol or the long GnRH-agonist protocol.

The intrafollicular levels of IGF-I and epidermal growth factor (EGF) were studied in women undergoing controlled ovarian hyperstimulation using the multidose GnRH-antagonist protocol or the long agonist protocol, in an attempt to elucidate whether GnRH-antagonists affect the levels of the two growth factors. The follicular fluid concentration of IGF-I, EGF, estradiol and progesterone were detected in 68 women undergoing ovarian hyperstimulation for intracytoplasmic sperm injection (ICSI) cycles. There were no differences in intrafollicular concentrations of EGF and IGF-I in the two studied groups. Additionally, we found no correlation between the intrafollicular levels of IGF-I or EGF and the ICSI outcome. The intrafollicular levels of IGF-I were positively correlated with those of progesterone. In conclusion, the intrafollicular levels of IGF-I and EGF do not seem to be influenced by the stimulation protocol. The intrafollicular levels of both growth factors can not serve as prognostic markers for the ICSI outcome.

Adult↗

PubMed2000

Optimization of TEOAE recording protocols: a linear protocol derived from parameters of a time-frequency analysis: a pilot study on neonatal subjects.

Linear and non-linear TEOAE protocols were compared in terms of nine parameters in order to define the protocol producing recordings with the highest signal quality (lowest noise and highest signal-to-noise ratio). The pilot project acquired data using ILO-92 apparatus from 220 neonates (397 ears) at the second/third day after birth in three European laboratories. A Gabor spectrogram time-frequency representation of the recordings showed considerable frequency dispersion in TEOAE latencies >4.0 ms. The data, analysed with a Wilcoxon test, indicated that a linear TEOAE protocol: (i) generates recordings of a lower noise and a higher signal-to-noise (S/N) ratio in the 2.0, 3.0, 4.0 kHz TEOAE bands; (ii) the increase in the S/N ratio can result in a decrement of the required number of TEOAE sweeps; (iii) the higher values of S/N can be used in the estimation of more robust pass-fail criteria, minimizing the percentage of false positives and negatives.

Acoustic Stimulation↗

PubMed2006

Comparison of outcome of clomiphene citrate/human menopausal gonadotropin/cetrorelix protocol and buserelin long protocol--a randomized study.

This study evaluates the efficacy of a stimulation protocol with clomiphene citrate (CC)/human menopausal gonadotropin (hMG)/cetrorelix and its effects on oocyte quality and endometrium. One hundred and twenty couples with male-factor infertility who were about to undergo their first intracytoplasmic sperm injection cycles were randomized into two groups. Sixty women were stimulated with the CC/hMG/cetrorelix protocol (cetrorelix group) and 60 received the buserelin long protocol (buserelin group). Fewer oocytes were recovered in the cetrorelix group than in the buserelin group (mean +/- standard deviation (SD): 11.1 +/- 4.0 vs. 17.3 +/- 5.8, p < 0.001); however, the percentages of metaphase II, metaphase I and germinal vesicle oocytes were similar between the two groups. Serum estradiol level was significantly lower in the cetrorelix than in the buserelin group (mean +/- SD: 2600.58 +/- 1189.11 vs. 3293.46 +/- 1221.49 pg/ml, p = 0.006), but the endometrial thickness was similar. The implantation rates (19.2% vs. 17.7%) and the pregnancy rates (41.7% vs. 40.0%) were similar between groups. The ampoules (mean +/- SD: 18.9 +/- 3.0 vs. 38.9 +/- 12.2, p < 0.001) and injections (mean +/- SD: 6.8 +/- 1.1 vs. 15.7 +/- 3.1, p < 0.001) of gonadotropin used were significantly lower in the cetrorelix group than in the buserelin group. No patients in either group developed a premature luteinizing hormone surge. The present study found no statistically significant difference between the two treatment modalities with regard to pregnancy rates.

Adult↗

PubMed2005

Eccentric decline squat protocol offers superior results at 12 months compared with traditional eccentric protocol for patellar tendinopathy in volleyball players.

BACKGROUND: Conservative treatment of patellar tendinopathy has been minimally investigated. Effective validated treatment protocols are required. OBJECTIVES: To investigate the immediate (12 weeks) and long term (12 months) efficacy of two eccentric exercise programmes for the treatment of patellar tendinopathy. METHODS: This was a prospective randomised controlled trial of 17 elite volleyball players with clinically diagnosed and imaging confirmed patellar tendinopathy. Participants were randomly assigned to one of two treatment groups: a decline group and a step group. The decline group were required to perform single leg squats on a 25 degrees decline board, exercising into tendon pain and progressing their exercises with load. The step group performed single leg squats on a 10 cm step, exercising without tendon pain and progressing their exercises with speed then load. All participants completed a 12 week intervention programme during their preseason. Outcome measures used were the Victorian Institute of Sport Assessment (VISA) score for knee function and 100 mm visual analogue scale (VAS) for tendon pain with activity. Measures were taken throughout the intervention period and at 12 months. RESULTS: Both groups had improved significantly from baseline at 12 weeks and 12 months. Analysis of the likelihood of a 20 point improvement in VISA score at 12 months revealed a greater likelihood of clinical improvements in the decline group than the step group. VAS scores at 12 months did not differ between the groups. CONCLUSIONS: Both exercise protocols improved pain and sporting function in volleyball players over 12 months. This study indicates that the decline squat protocol offers greater clinical gains during a rehabilitation programme for patellar tendinopathy in athletes who continue to train and play with pain.

Adolescent↗

PubMed2004

Reflexions about imaging technique and examination protocol 2. MR-examination protocol.

Adequate imaging protocol is crucial for any imaging technique. As MR is a time consuming examination, the physician serves the patient best, when he/she makes the best choice of sequences, which answer the question of the clinician and provide a definite diagnosis. Although any patient requires an individual protocol, some general rules should be known.

Clinical Protocols↗