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At least 307 records · Page 17Linked to original sources
PubMed1998

Radiation dose and image quality in spiral computed tomography: multicentre evaluation at six institutions.

The purpose of this study was to evaluate the correlation of radiation dose with image quality in spiral CT. Seven clinical protocols were measured in six different radiological departments provided with four different types of high specification spiral CT scanners. Central and surface absorbed doses were measured in acrylic. The practical CT dose index (PCTDI) was calculated for seven clinical examination protocols and one standardized protocol using identical parameters on four different spiral CT scanners with a dedicated ionization chamber inserted into PMMA phantoms. For low contrast measurements, a cylindrical three-dimensional (3D) phantom (different sized spheres of defined contrast) was used. Image noise was measured with a cylindrical water phantom and high contrast resolution with a Perspex hole phantom. Image quality phantoms were scanned using the parameters of the clinical protocols. Images were randomized, blinded and read by six radiologists (one from each institution). PCTDI values for four different scanners varied up to a factor between 1.5 (centre) and 2.2 (surface) for the standardized protocol. A greater degree of variation was observed for seven clinical examination protocols of the six radiological departments. For example, PCTDI varied up to a factor between 1.7 (cerebrum protocol) and 8.3 (abdomen paediatric protocol). Low contrast resolution correlates closely with dose. An improvement in detection from 8 mm to 4 mm sized spheres needs approximately a ten-fold increase in dose. Noise shows a moderate correlation with PCTDI. High contrast resolution of clinical protocols is independent of PCTDI within a certain range. Differences in modern CT scanner technology seem to be of less importance for radiation exposure than selection of protocol parameters in different radiological institutes. Future discussion on guidelines regarding optimal (patient adapted) tube current for clinical protocols is desirable.

Brain↗
PubMed1994

[Methods of second trimester pregnancy termination and evacuation of in utero dead fetuses. Value of mifepristone].

The authors present a review of the literature on the current methods of second trimester termination of pregnancy and labour induction for fetal death. Prostaglandins are efficient, but may cause side-effects (nausea, vomiting) and painful contractions. Natural PGs (PGF2 alpha and PGE2), induce fetal expulsion in about 80% of cases within 24 h. PG analogues (sulprostone and gemeprost), are, presently, more used, and lead to fetal expulsion in 90% of cases, with less side-effects. Mifepristone, an antiprogesterone steroid, increases uterine activity, sensitizes myometrium to PG action, and induces cervical priming. Several clinical trials point out the advantage of mifepristone use, 24 to 48 h before PG. So, the duration of termination, and the PG dosage are reduced by half. A clinical protocol for second trimester termination, with mifepristone, and PG analogues, is proposed. In case of fetal death, labour induction is now accepted. The expulsion of a dead fetus is easier than a live one. PG and analogues show a good efficacy: > 90% success within 24 h. Mifepristone, alone, leads to fetal expulsion in 2/3 of cases, within 72 h, without side-effects. A clinical protocol of induction with mifepristone and PG in case of fetal death is proposed. In these two difficult clinical cases, mifepristone is of great interest, in reducing duration of termination, and increasing comfort and security for the patients.

Abortion, Induced↗
PubMed1997

Psychologists' accuracy in identifying neuropsychological test protocols of clinical malingerers.

Neuropsychology practitioners' accuracy in detecting malingering (based on neuropsychological test data alone) was investigated. Four test protocols had been produced by clinical malingerers who were identified by below-chance forced-choice test (FCT) results. For two of the cases observation/ surveillance data also indicated malingering. Two test protocols had been produced by severely head-injured individuals. Sixty psychologists reviewed a malingered test protocol and 26 reviewed data of a head-injured patient. Error rates (diagnosis of cerebral dysfunction without identifying malingering) ranged from zero to 25% and averaged 10% across the four malingered cases. Eight percent of the psychologists diagnosed malingering in the severely head-injured cases. Psychologists who received FCT data were significantly more confident in their diagnoses than were psychologists who did not receive FCT results, but they were not more accurate. The results suggest that neuropsychologists are capable of accurately detecting malingering, at least for obvious cases.

Journal Article↗
PubMed2006

[Evaluation and diagnosis of patients with genetic mental retardation: standardised clinical evaluation protocols].

INTRODUCTION AND AIMS: Mental retardation (MR) affects approximately 2-3% of the general population and around 75% of the known causes of MR are thought to have a genetic origin. The aim of this work is to describe a standardised model of diagnostic approach to patients with mental retardation of a genetic origin (MRGO). DEVELOPMENT: The clinician has to draw up a detailed case history and carry out a thorough dysmorphological physical examination that enables a reasonable differential diagnosis to be reached. The next step will be to request the complementary studies needed to confirm or reject the initial suspected diagnosis. Accurate information about the personal, prenatal (pregnancy) and perinatal (childbirth) history must also be collected. The postnatal history will also provide relevant clinical information. The familial history is a fundamental element of any genetic disease and must be gathered by drawing up the family tree or lineage. The physical and dysmorphological examination must be ordered, completed and detailed, and measurements of the somatometric parameters required to demonstrate and quantify the existence of an anomaly in any anatomical structure will also have to be made. Photos of the patient are a great aid because they allow comparison with recognisable dysmorphic syndromes. The last phase involves requesting complementary studies, including consultations with other specialists. The confirmation or exclusion of MR usually results from biochemical-metabolic, cytogenetic or molecular studies. CONCLUSIONS: In cases of MRGO a good patient record accompanied by a thorough physical and dysmorphological study allow the clinical geneticist to orientate the diagnosis in the right direction and to request the specific genetic laboratory tests to confirm (or reject) its causation.

Adolescent↗
PubMed2006

Blood test ordering for unexplained complaints in general practice: the VAMPIRE randomised clinical trial protocol. [ISRCTN55755886].

BACKGROUND: General practitioners (GPs) frequently order blood tests when they see patients presenting with unexplained complaints. Due to the low prevalence of serious pathology in general practice, the risk of false-positive test results is relatively high. This may result in unnecessary further testing, leading to unfavourable effects such as patient anxiety, high costs, somatisation and morbidity. A policy of watchful waiting is expected to lower both the number of patients to be tested and the risk of false-positive test results, without missing serious pathology. However, many general practitioners experience barriers when trying to postpone blood testing by watchful waiting. The objectives of this study are (1) to determine the accuracy of blood tests in patients presenting with unexplained complaints in terms of detecting pathology, (2) to determine the accuracy of a watchful waiting strategy and (3) to determine the effects of a quality improvement strategy to promote the postponement of blood test ordering by GPs for patients with unexplained complaints. DESIGN: General practices are randomised over three groups. Group 1 is instructed to order blood tests immediately, group 2 to apply a watchful waiting policy and group 3 also to postpone testing, but supported by our quality improvement strategy. The trial consists of two sub-studies: a diagnostic study at patient level (group 1 versus groups 2 and 3) and a quality improvement study at GP level (group 2 versus group 3). The diagnostic strategy to be used involves of both customary and innovative tests. The quality improvement strategy consists of two small-group meetings and a practice outreach visit. Patient follow-up ends at 12 months after the initial consultation. Primary outcome measures are the accuracy and added value of blood tests for detecting pathology, the effect of a 4-week postponement of test ordering on the blood test characteristics and the quantity of tests ordered. Secondary outcome measures are the course of complaints, quality of life, satisfaction with care, anxiety of patients and practitioners, determinants of physicians' behaviour, health care utilisation and costs. DISCUSSION: The innovative aspect of this trial is that it combines a clinical-epidemiological study and a quality of care study.

Adult↗
PubMed2004

The role of optimal healing environments in patients undergoing cancer treatment: clinical research protocol guidelines.

Integrative cancer care (ICC) is the treatment of patients with cancer, under physician supervision, with appropriate conventional treatments in a healing context based on insights from research on nutrition, biochemistry, exercise, and psycho-oncology. It uses validated techniques and practitioners of complementary and alternative medicine (CAM), and strategies for enhancing treatment and side-effect management such as chronomodulated chemotherapy, therapies to reduce treatment resistance, and innovative assessments for individualizing treatment plans. The elements of ICC align well with the concepts of optimal healing environments (OHE). Expectations of well-being are fostered; transformative self-care practices are common therapeutic tools; development of healing presence among staff and therapeutic alliances with patients are emphasized; instruction in health-promoting behavior is standard; and collaborative integration of CAM in the practice is typical. Based on the authors' clinical experience, an OHE for patients with cancer is described and suggestions for meaningful research are identified.

Adaptation, Psychological↗
PubMed2000

Suicide gene therapy toxicity after multiple and repeat injections in patients with localized prostate cancer.

PURPOSE: We assess risks, toxicity and side effects of multiple and repeat in situ suicide gene therapy in patients with localized prostate cancer. MATERIALS AND METHODS: The study population comprised patients with localized prostate cancer receiving multiple and/or repeat intraprostatic injections of a replication deficient adenovirus containing the herpes simplex virus thymidine kinase (HSV-tk) gene. Intravenous ganciclovir or oral valaciclovir was given for 14 days after injection. Patients were recruited from 4 different clinical protocols in studies of toxicity and efficacy of suicide gene therapy, and closely monitored for toxicity and side effects during and after treatment. Toxicity was graded according to the Cancer Therapy Evaluation Program common toxicity criteria published by the National Cancer Institute. RESULTS: A total of 52 patients were treated under these clinical protocols with a total of 76 gene therapy cycles. Toxic events were recorded in 16 of 29 patients (55.2%) who were given multiple viral injections into the prostate, 7 of 20 (35%) who received 2 cycles of "suicide" gene therapy and 3 of 4 (75%) who received a third course of gene therapy. All toxic events after multiple or repeat injections were mild (grades 1 to 2) and resolved completely once the therapy course was terminated. No additive toxicity was noted in patients receiving repeat gene therapy cycles. Mean followup was 12.8 months (range 3 to 34). Preliminary results for 28 patients in 2 clinical protocols indicated a mean decrease of 44% in PSA in 43%. CONCLUSIONS: Direct injection into the prostate of a replication defective adenovirus containing the HSV-tk gene followed by intravenous ganciclovir is safe even in repeat cycles.

Acyclovir↗
PubMed2001

Brain activity and cognitive status in pediatric patients: development of a clinical assessment protocol.

The purpose of this study was to test the validity of a new computerized task to assess children's cognitive problem-solving skills using the brain event-related potentials. This event-related potential-computerized cognitive problem-solving task does not require a child to give a verbal or motor (ie, pointing) response. The event-related potential waveforms were recorded from 20 typically developing children. Two nonverbal, problem-solving tasks (tasks 1 and 2) were developed for each of two age groups (5 and 6 years). For each task, single pictures, taken from an existing standardized test of nonverbal problem solving, were individually and sequentially presented on a computer screen. One of the seven pictures was classified as incongruent or outside category; it did not belong with the other pictures. As predicted, the event-related potential amplitudes were significantly larger to the outside- versus within-category pictures. This effect was found for tasks 1 and 2 for the 5- and 6-year-old children. Children as young as 5 years of age reliably exhibit brain activity, which can be used to infer cognitive problem-solving skill. This assessment paradigm may eventually serve as a clinically useful adjunct to a thorough neurologic and neurodevelopmental assessment of selected pediatric populations, such as those presenting with moderate-severe cerebral palsy whose expressive language and motor skills are notably impaired.

Age Factors↗
PubMed2006

A modified goal-directed protocol improves clinical outcomes in intensive care unit patients with septic shock: a randomized controlled trial.

We evaluated whether a goal-directed protocol, without measurement of central venous oxygen saturation, would improve survival in medical intensive care unit (ICU) patients with septic shock. This is a prospective, controlled study in a 24-bed medical ICU at a tertiary care hospital. From a total of 241 consecutive patients with septic shock, 224 were randomly assigned to receive therapy with or without a written protocol using central venous pressure, mean arterial pressure, and urine output as therapeutic goals. Baseline characteristics were similar between groups. Implementation of goal-directed therapy caused a more rapid reversal of persistent shock (47 +/- 22.8 vs. 65.4 +/- 32.1 h, P = 0.006) and decreases of ICU (50% vs. 67.2%, P = 0.009) and in-hospital (53.7% vs. 71.6%, P = 0.006) mortality rates compared with non-goal-directed therapy. Patients receiving goal-directed therapy also had less risk for developing central nervous system or renal failure than patients without. Patients with goal-directed therapy received more fluid during the period of persistent shock (136.2 +/- 119 vs. 88.6 +/- 57.7 mL h, P = 0.034) and less delay in vasopressor administration (78 +/- 22.2 vs. 104.4 +/- 29 min, P = 0.001) than patients with non-goal therapy. Implementation of a goal-directed protocol improves survival and clinical outcomes in ICU patients with septic shock. These benefits may arise from adequate fluid resuscitation, earlier vasopressor administration, rapid shock reversal, and protection of major organ function. With central venous oxygen saturation measurement to detect tissue perfusion, the clinical outcomes may be further improved.

Aged↗
PubMed2004

Mobilized blood CD34+ cells transduced and selected with a clinically applicable protocol reconstitute lymphopoiesis in SCID-Hu mice.

We developed a clinically applicable gene transfer procedure into mobilized peripheral blood (MPB) CD34(+) hematopoietic progenitor cells, based on single viral exposure and selection of engineered cells. CD34(+) cells were transduced with a retroviral vector carrying the truncated form of the nerve growth factor receptor (Delta NGFR) marker gene, and immunoselected for Delta NGFR expression. Optimal time and procedure for viral exposure, length of culture, and transgene expression of MPB CD34(+) cells were determined using in vitro assays. The multipotent capacity of MPB CD34(+)-transduced cells was demonstrated in the SCID-hu bone/liver/thymus mouse model. Transduced Delta NGFR(+) cells retained 50% of long-term culture-colony forming cells (LTC-CFC) compared to unmanipulated CD34(+) cells. In SCID-hu mice, 52% of CD45(+) cells, 27% of CD34(+) cells, 49% of B cells, and more than 50% of T cells were derived from transplanted CD34(+)/Delta NGFR(+) cells. Furthermore, transplantation of purified transduced cells greatly reduced the competition with untransduced progenitors occurring in unselected grafts. These data demonstrate that MPB CD34(+) cells, transduced with a single viral exposure and selected by transgene expression, retain multilineage reconstitution capacity and remarkable transgene expression.

Animals↗
PubMed1993

Mechanism of a clinically relevant protocol to induce tolerance of cardiac allografts. Perioperative donor spleen cells plus cyclosporine suppress IL-2 and interferon-gamma production.

Many groups have reported that preoperative injection of donor-derived whole spleen cells or major histocompatibility complex antigens prolongs organ allograft survival in experimental models, but the immunosuppressive mechanism(s) responsible remains unclear. A central, confounding issue is how to reconcile documentation of comparable levels of mRNA for IL-2 in suppressed versus control groups with obvious host hyporesponsiveness. We used a model of tolerance induction involving perioperative injection of donor spleen cells and injection of CsA at day 2 after transplant to analyze the serial expression of several proinflammatory cytokines relevant to development of alloresponsiveness within cardiac allografts and recipients' spleens. Four experimental groups of Lewis rats receiving vascularized heterotopic cardiac allografts from Brown Norway (BN) donors were evaluated: (1) untreated controls; (2) animals receiving intraoperative injection of donor BN spleen cells; (3) those receiving a single injection of CsA on day 2 post-Tx; and (4) animals given the combination of intraoperative BN spleen cells and CsA on day 2 post-Tx. Graft survival was significantly prolonged in Lewis rats receiving the combined spleen cell/CsA therapy (mean 64 days, with 40% of grafts surviving > 100 days, n = 15) compared with acute rejection at about 8 days (range 6-13, n = 20) in each of the 3 control groups (P < 0.0001). By comparison with acutely rejecting allografts in the control untreated group at day 7 post-Tx, allografts in rats receiving the combined perioperative spleen cell/CsA treatment showed (1) significantly reduced graft cellularity and interstitial edema; (2) significantly decreased features of immune activation, including infiltration by mononuclear cells expressing IL-2R or proliferating cell nuclear antigen; (3) decreased intragraft expression of the cytokines IL-2 and IFN-gamma; and (4) suppression of endothelial activation as evidenced by both failure of up-regulation of intracellular adhesion molecule-1 and maintenance of thrombomodulin expression by graft endothelium. Analysis of sections of recipients' spleens showed that spleen cell/CsA therapy led to significant reductions versus untreated controls, in expression of IL-2, IFN-gamma, and IL-2R. Similarly, mixed lymphocyte response cultures showed that responder cells from rats receiving combined therapy proliferated by 93-95% less than untreated animals. Our results suggest that the efficacy of this clinically relevant protocol is associated with suppression of IL-2 or IFN-gamma protein production, and that in the absence of such molecules, it appears that T cell-receptor occupancy by alloantigens readily induces a state of anergy in vivo.

Animals↗
PubMed2000

Continence for women: a test of AWHONN's evidence-based protocol in clinical practice.

OBJECTIVE: To test the effectiveness of an evidence-based protocol for urinary incontinence in increasing identification of women with the condition and improving their outcomes. DESIGN: Prospective formative evaluation study. SETTING: Twenty-one public, private, and other women's health care sites. PARTICIPANTS: Women in ambulatory care settings (N = 1474) provided descriptive statistics. Clinical outcomes were tested in 132 cases for whom pre- and posttreatment data were available. INTERVENTIONS: Standardized screening and baseline follow-up forms were used to minimize time burden on clinicians; bladder and pelvic floor muscle training materials were provided to clinicians for distribution. MAIN OUTCOME MEASURES: Self-reported frequency, volume, and quality of life related to incontinence and cost of self-management were used to assess protocol effectiveness. RESULTS: Frequency of incontinence episodes, estimated volume lost per episode, and the cost of self-management decreased. Quality of life improved, as reflected in decreased bother attributed to incontinence and in the number of women avoiding activities such as shopping, exercising, or travel because of incontinence. CONCLUSIONS: This simple program of pelvic floor muscle and bladder training, as it has been systematically implemented in a variety of ambulatory women's health care settings, has benefitted women's continence status. The results of this project strongly support widespread application.

Journal Article↗
PubMed2005

Incidence of anaphylactoid reactions to isosulfan blue dye during breast carcinoma lymphatic mapping in patients treated with preoperative prophylaxis: results of a surgical prospective clinical practice protocol.

BACKGROUND: Severe anaphylactoid reactions to isosulfan blue dye requiring resuscitation are reported to occur in 1.1% of patients with breast carcinoma undergoing sentinel lymphadenectomy. In December 2001, the authors began administering a prophylactic regimen before dye injection to determine whether prophylaxis reduced the incidence of life-threatening reactions. METHODS: All patients were mapped with technetium-99m-labeled sulfur colloid. Those also receiving isosulfan blue dye were administered a glucocorticoid, diphenhydramine, and famotidine intravenously just before or at induction of anesthesia. Adverse reactions at the time of surgery were analyzed. RESULTS: Between December 2001 and July 2003, 1013 consecutive patients underwent sentinel lymphadenectomy for breast carcinoma. Six hundred sixty-seven patients (65.8%) received prophylaxis and isosulfan blue dye, 33 (3.3%) received prophylaxis but no dye, 12 (1.2%) received dye but no prophylaxis, and 301 (29.7%) received no prophylaxis or dye. Blue urticaria and facial edema were observed in 3 (0.5%) of 667 patients receiving prophylaxis and dye and in 1 (8.3%) of 12 patients receiving dye but no prophylaxis. There were no episodes of hypotension, and no patients required vasopressors, ventilatory support, or intensive care observation. Adverse reactions to agents other than blue dye were observed in 2 (0.3%) of 667 patients receiving prophylaxis and dye and in 3 (1.0%) of 301 receiving no prophylaxis and no dye (P = 0.1773). CONCLUSIONS: Preoperative prophylaxis was found to reduce the severity, but not the overall incidence, of adverse reactions to isosulfan blue dye. No life-threatening reactions were noted in patients treated with preoperative prophylaxis. Based on these results, the authors now routinely recommend administration of prophylaxis to patients receiving isosulfan blue for lymphatic mapping and sentinel lymph node biopsy.

Aged↗
PubMed2005

Implementing a clinical assessment protocol for sensory and skeletal function in diabetic neuropathy patients at a university hospital in Brazil.

CONTEXT AND OBJECTIVE: Physiotherapy can contribute towards recovering or preventing physical and sensory alterations in diabetic neuropathy patients. Our objective was to create and apply a protocol for functional assessment of diabetic neuropathy patients' lower limbs, to guide future physiotherapy. DESIGN AND SETTING: Clinical study at the University Hospital and teaching/research center of Universidade de São Paulo. METHODS: An intentional sample of diabetic neuropathy patients was utilized. The protocol was divided into: (1) preliminary investigation with identification of relevant clinical diabetes and neuropathy characteristics; (2) thermal, tactile and proprioceptive sensitivity tests on the feet; (3) evaluations of muscle function, range of motion, lower limb function, foot anthropometry. RESULTS: The patients' mean age was 57 years, and they had had the diagnosis for 13 years on average. Distal numbness and tingling/prickling were present in 62% and 67%, respectively. There were tactile sensitivity alterations above the heel in 50%, with thermal sensitivity in 40% to 60%. The worst muscle function test responses were at the triceps surae and foot intrinsic muscles. Longitudinal plantar arches were lowered in 50%. Decreased thermal and tactile sensitivity of the heels was found. There was a general reduction in range of motion. CONCLUSIONS: The results provided detailed characterization of the patients. This protocol may be easily applied in healthcare services, since it requires little equipment, at low cost, and it is well understood by patients.

Adult↗
PubMed2006

Comparison of the effectiveness of three manual physical therapy techniques in a subgroup of patients with low back pain who satisfy a clinical prediction rule: study protocol of a randomized clinical trial [NCT00257998].

BACKGROUND: Recently a clinical prediction rule (CPR) has been developed and validated that accurately identifies patients with low back pain (LBP) that are likely to benefit from a lumbo-pelvic thrust manipulation. The studies that developed and validated the rule used the identical manipulation procedure. However, recent evidence suggests that different manual therapy techniques may result similar outcomes. The purpose of this study is to investigate the effectiveness of three different manual therapy techniques in a subgroup of patient with low back pain that satisfy the CPR. METHODS/DESIGN: Consecutive patients with LBP referred to physical therapy clinics in one of four geographical locations who satisfy the CPR will be invited to participate in this randomized clinical trial. Subjects who agree to participate will undergo a standard evaluation and complete a number of patient self-report questionnaires including the Oswestry Disability Index (OSW), which will serve as the primary outcome measure. Following the baseline examination patients will be randomly assigned to receive the lumbopelvic manipulation used in the development of the CPR, an alternative lumbar manipulation technique, or non-thrust lumbar mobilization technique for the first 2 visits. Beginning on visit 3, all 3 groups will receive an identical standard exercise program for 3 visits (visits 3,4,5). Outcomes of interest will be captured by a therapist blind to group assignment at 1 week (3rd visit), 4 weeks (6th visit) and at a 6-month follow-up. The primary aim of the study will be tested with analysis of variance (ANOVA) using the change in OSW score from baseline to 4-weeks (OSWBaseline - OSW4-weeks) as the dependent variable. The independent variable will be treatment with three levels (lumbo-pelvic manipulation, alternative lumbar manipulation, lumbar mobilization). DISCUSSION: This trial will be the first to investigate the effectiveness of various manual therapy techniques for patients with LBP who satisfy a CPR.

Adolescent↗
PubMed2002

Lasers and soft tissue curettage: an update.

This article describes how certain dental laser instruments are used adjunctively in the initial phase of the treatment of periodontal disease. The author explains the fundamentals of laser science and tissue interaction and lists the steps of the clinical protocol. Examples of treated clinical cases are shown, and the safety and effectiveness of this instrumentation are discussed.

Clinical Protocols↗
PubMed1987

Quality assurance in a public health agency.

Quality assurance (QA) activities in public health programs typically are fragmented. The Division of Public Health of Maricopa County in Phoenix decided to develop a comprehensive QA program in 1981 that involved both the development of clinical protocols and the formalization of procedures for planning, executing, and following up on QA studies. A clinical protocols committee was formed to generate protocol manuals that serve as the principal criteria source for QA studies. A QA committee was also established to set guidelines for studies and to supervise their execution. Thus far, the QA program has resulted in a significant increase in QA activities within the public health division and improvements in many aspects of patient care.

Arizona↗