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At least 235 records · Page 13Linked to original sources
PubMed2006

Probability model of the inaccuracy of residual stromal thickness prediction to reduce the risk of ectasia after LASIK part II: quantifying population risk.

PURPOSE: To derive a statistical model to estimate the rate of excessive keratectomy depth below a selected cut-off residual stromal thickness (RST) given a minimum target RST and specific Clinical Protocol; apply the model to estimate the RST below which ectasia appears likely to occur and back-calculate the safe minimum target RST that should be used given a specific Clinical Protocol. METHODS: Myopia and corneal thickness distribution were modeled for a population of 5212 eyes that underwent LASIK. The probability distribution of predicted target RST error (Part I) was used to calculate the rate of excessive keratectomy depth for this series. All treatments were performed using the same Clinical Protocol; one surgeon, Moria LSK-One microkeratome, NIDEK EC-5000 excimer laser, Orbscan pachymetry, and a minimum target RST of 250 microm--the Vancouver Clinical Protocol. The model estimated the RST below which ectasia appears likely to occur and back-calculated the safe minimum target RST. These values were recalculated for a series of microkeratomes using published flap thickness statistics as well as for the Clinical Protocol of one of the authors-the London Clinical Protocol. RESULTS: In the series of 5212 eyes, 6 (0.12%) cases of ectasia occurred. The model predicted an RST of 191 microm for ectasia to occur and that a minimum target RST of 329 microm would have reduced the -rate of ectasia to 1: 1,000,000 for the Vancouver Clinical Protocol. The model predicted that the choice of microkeratome varied the rate of ectasia between 0.01 and 11,623 eyes per million and the safe minimum target RST between 220 and 361 microm. The model predicted the rate of ectasia would have been 0.000003: 1,000,000 had the London Clinical Protocol been used for the Vancouver case series. CONCLUSIONS: There appears to be no universally safe minimum target RST to assess suitability for LASIK largely due to the disparity in accuracy and reproducibility of microkeratome flap thickness. This model may be used as a tool to evaluate the risk of ectasia due to excessive keratectomy depth and help determine the minimum target RST given a particular Clinical Protocol.

Corneal Diseases↗
PubMed2003

Antibiotic prophylaxis for external ventricular drains in neurosurgical patients: an audit of compliance with a clinical management protocol.

OBJECTIVE: To examine the clinical impact of a management protocol for external ventricular drains (EVD). PATIENTS AND METHODS: All patients with EVDs over a six-month period were reviewed retrospectively. Data concerning the indications for EVD placement, antibiotics and cerebrospinal fluid (CSF) analyses were collected. A restrictive antibiotic protocol (e.g. intravenous cephalothin 1g 6-hourly for 24 hours, unless other antibiotics were prescribed for a documented pre-existing infection) was introduced for all patients requiring placement of an EVD during the following six months and all patients were observed prospectively. Daily CSF samples were collected under sterile conditions and examined for organisms, cells, glucose and protein and sent for microbiological culture. External ventricular drains were removed after five days and replaced if further monitoring or CSF drainage was required. Adherence to the protocol and the incidence of ventriculitis was determined. RESULTS: Twelve patients with EVDs were identified during the 6 month pre-protocol period and 15 patients with EVDs were identified during the 6 month post-protocol period. There was no significant difference between the total (72 vs 88 days) and mean (6 vs 5.9 days) drain placement times between the two groups. There was no significant difference between the mean numbers of CSF samples in the two groups. CSF aspirates were not analysed in 35/72 samples (49%) in the pre-protocol group compared with 45/88 (51%) samples in the post-protocol group. Positive CSF Gram-stains were found in 3/12 (25%) patients in the pre-protocol group and in 0/15(0%) in the post-protocol group. Positive CSF cultures decreased significantly in the post-protocol group (17 vs 5, p = 0.0009). Prophylactic antibiotics were prescribed in 5/12 (42%) patients in the pre-protocol group compared with 12/15 (80%) patients in the post-protocol group. CONCLUSIONS: The protocol was associated with a statistically significant improvement in compliance with antibiotic prescription and reduction in the incidence of positive CSF cultures.

Journal Article↗
PubMed2003

Composite tissue allotransplantation in chimeric hosts part II. A clinically relevant protocol to induce tolerance in a rat model.

BACKGROUND: We and others have shown that mixed allogeneic chimerism induces donor-specific tolerance to composite tissue allografts across major histocompatibility complex barriers without the need for immunosuppression. However, a delay period between bone marrow transplantation and limb allotransplantation is required, making such protocols impractical for clinical application. This study eliminates this delay period in a rat hind limb allotransplantation model by performing mixed allogeneic chimerism induction and transplantation "simultaneously." METHODS: Group 1 included controls in which naïve Wistar Furth (WF) hosts received ACI hind limbs. Group 2 included (ACI-->WF) chimeras that received limbs from third-party donors (Fisher), and group 3 included chimeras that received irradiated (1,050 cGy) ACI limbs. In group 4, WF hosts conditioned with 950 cGy received irradiated (1,050 cGy) ACI limbs followed by infusion of 100 x 10(6) ACI T-cell-depleted bone marrow cells and immunotherapy (tacrolimus and mycophenolate mofetil) for 28 days. Group 5 animals received the same treatment as group 4 animals without immunotherapy. RESULTS: The rats in groups 1 and 2 rejected their limbs within 10 days. Only one rat in group 4 survived to the end of the study. Groups 3 and 5 demonstrated long-term limb survival without rejection or graft-versus-host disease. High levels of donor chimerism (>80%) were achieved and maintained throughout the study. Mixed lymphocyte reaction assays in both groups revealed donor-specific hyporesponsiveness with vigorous third-party reactivity. CONCLUSIONS: This study demonstrated that infusion of donor bone marrow cells into conditioned hosts immediately after limb transplantation results in stable mixed chimerism, robust tolerance, and reliable limb allograft survival.

Animals↗
PubMed1993

Opiate detoxification protocols. A clinical manual.

The purpose of any opiate detoxification protocol is to minimize or eliminate the signs and symptoms associated with opiate withdrawal, thereby decreasing the chances of relapse to opiate dependence. In the last few years, because of the development of new medications such as clonidine, for the treatment of opiate withdrawal, a number of new protocols have been developed. Four different types of protocols are reviewed and outlined: methadone substitution/detoxification, codeine or other opiate substitution/detoxification, opiate of choice detoxification, and buprenorphine substitution/detoxification. In addition, six protocols utilizing clonidine are presented, including a protocol utilizing opiate antagonist precipitated withdrawal. Finally, two protocols that utilize naltrexone are outlined, and adjunct medications potentially useful in opiate detoxification are reviewed. Some suggestions for the treatment of drug-seeking behavior during detoxification and the advantages and disadvantages of the various protocols are summarized.

Administration, Cutaneous↗
PubMed1997

A standardized weight-based heparin protocol. Improving clinical outcomes.

A 3-year study evaluated various heparin dosing regimens. The clinical outcomes of a traditional non-weight-based method were compared with a newly designed standard protocol that related the heparin dose to patient weight. The relative time to achieve therapeutic anticoagulation, the number of additional intravenous heparin injections required and the length of hospitalization were all evaluated. Overall, it was found that the individualized weight-based protocol improved clinical outcomes and lowered medical costs.

Anticoagulants↗
PubMed1993

Impact of clinical trial protocols on patient care systems at the University of Texas M.D. Anderson Cancer Center.

Clinical trial protocols represent a significant component of the research program at the University of Texas M.D. Anderson Cancer Center. Currently, there are nearly 800 active protocols using more than 150 investigational drugs. Sponsors of these trials include the National Cancer Institute, numerous pharmaceutical companies, and a variety of other funding sources. Because of our large patient base, however, routine participation in cooperative groups is limited. The impact of clinical trial protocols on patient care systems is a growing concern that is addressed primarily by the Surveillance Committee at M.D. Anderson. Like many institutional review boards, this committee reviews all protocols and must grant approval before the activation of any clinical trial. The issues of medical ethics, including a risk-benefit assessment for research subjects, equitable patient selection, safeguards for economically disadvantaged populations, and the general requirements for informed consent, also fall under the purview of this board. For any comprehensive cancer center to succeed, it must have strong research programs that enhance treatment options for patients. The crisis in financing health care significantly threatens the viability of cancer research. Reimbursement for the related costs of individuals participating in clinical trials has become a battle ground for third-party payers. The resulting economic risk is shared by health care providers and patients. As a consequence, many cancer centers, including M.D. Anderson, have initiated an economic-impact analysis for protocols as a component of the review process. This analysis includes an estimation of the patient care costs compared to the funding allocated to support the research. Future research will include pharmacoeconomic analysis and other ways to relate the costs and outcomes of treatment protocols. In the interim, we must monitor reimbursement trends for patients enrolled in clinical trials closely and amend the informed consent process to include a discussion of potential economic risk or hardship to patients if insurance claims are denied. Cancer care providers, third-party payers, the federal government, and society at large must work together to address the funding of cancer research and patient care.

Cancer Care Facilities↗
PubMed2004

Epidemiology of alcohol and other drug use among motor vehicle crash victims admitted to a trauma center.

The objectives of this research were to (1) determine the incidence and prevalence of alcohol and other drug use among motor vehicle crash (MVC) victims admitted to a regional Level-I trauma center, and (2) to examine the utility of using a rapid point-of-collection (POC) drug-testing device to identify MVC patients with drug involvement. Blood and urine specimens were routinely collected per clinical protocol for each MVC victim at the time of admission. Blood alcohol concentration (BAC) levels were determined per standard clinical protocol. Clinical urine specimens were routinely split so that a POC drug-testing device for the detection of commonly abused drugs (Marijuana, Cocaine, Amphetamines, Methamphetamines, and Opiates) could be compared to that of the standard hospital laboratory analysis of each urine specimen (which also included Barbiturates and Benzodiazepines). In the six-month period of this study, nearly two-thirds of trauma center admissions were victims of motor vehicle crashes. During this time, blood and urine was collected from 322 MVC victims. Toxicology results indicated that 59.3% of MVC victims tested positive for either commonly abused drugs or alcohol. More patients tested positive for drug use than tested positive for alcohol, with 33.5% testing positive for drug use only, 15.8% testing positive for alcohol use only, and 9.9% testing positive for both drugs and alcohol. Less than half (45.2%) of the substance-abusing patients in this study would have been identified by an alcohol test alone. After alcohol, marijuana and benzodiazepines were the most frequently detected drugs. Point of collection (POC) test results correlated well with laboratory results and provide important information to initiate rapid intervention/treatment for substance use problems among injured patients.

Accidents, Traffic↗
PubMed2006

Participatory design of a collaborative clinical trial protocol writing system.

OBJECTIVE: To explore concrete approaches to socio-technical design of collaborative healthcare information systems and to design a groupware technology for collaborative clinical trial protocol writing. METHOD: We conducted "quick and dirty ethnography" through semi-structured interviews, observational studies, and work artifacts analysis to understand the group work for protocol development. We used participatory design through evolutionary prototyping to explore the feature space of a collaborative writing system. Our design strategies include role-based user advocacy, formative evaluation, and change management. RESULTS: Quick and dirty ethnography helped us efficiently understand relevant work practice, and participatory design helped us engage users into design and bring out their tacit work knowledge. Our approach that intertwined both techniques helped achieve a "work-informed and user-oriented" design. This research leads to a collaborative writing system that supports in situ communication, group awareness, and effective work progress tracking. The usability evaluation results have been satisfactory. The system design is being transferred to an organizational tool for daily use.

Clinical Protocols↗
PubMed1991

Excessive test costs in clinical research protocols.

The escalation of health care costs has become an essential part of clinical research. Some clinical research protocols appear to require excessive laboratory testing. A review of an adjuvant breast cancer trial compared the costs of the required laboratory tests to those deemed "essential" to meet the goals of the study. A reduction of 59% in the laboratory tests over 6 1/2 years was accomplished. It is apparent that a significant reduction in cost can be accomplished. With such efforts, greater participation in clinical trials might occur. These observations are relevant in cancer education programs that involve patients on research protocols.

Breast Neoplasms↗
PubMed1977

New practical treadmill protocol for clinical use.

A new continuous treadmill protocol (USAFSAM) has been designed using a constant treadmill speed (3.3 miles/hour) and regular equal increments in treadmill grade (5%/3min). The constant treadmill speed requires only initial adaptation in patient stride, reduces technician adjustments and produces less electrocardiographic motion artifact than do protocols using multiple or higher treadmill speeds, or both. The regular equal increments in treadmill grade are easy to implement and provide a larger number of work loads than do protocols that are discontinuous or require larger changes in work load. The USAFSAM protocol was compared with the older Balke-Ware protocol in 26 healthy men (aged 30 to 59 years). Each fasting subject completed two maximal treadmill tests from each protocol. Measurements included minute heart rate from the electrocardiogram, auscultatory blood pressures and oxygen consumption obtained with standard techniques. Similarities in between-protocol measurements for submaximal and maximal treadmill efforts were impressive; differences were small and unimportant. Further, both protocols showed equal reproducibility for the measurements noted. Importantly, time to maximal effort was reduced by 24% with the USAFSAM protocol. The USAFSAM treadmill protocol has since been used in more than 500 clinical and screening examinations, thus confirming its advantages and practicality for routine clinical stress testing. Normal reference values previously established for the Balke-Ware protocol are shown to apply to the new USAFSAM protocol as well.

Adult↗
PubMed1996

Predicting functional capacity during treadmill testing independent of exercise protocol.

Clinically useful estimates of VO2max from treadmill tests (GXT) may be made using protocol-specific equations. In many cases, GXT may proceed more effectively if the clinician is free to adjust speed and grade independent of a specific protocol. We sought to determine whether VO2max could be predicted from the estimated steady-state VO2 of the terminal exercise stage. Seventy clinically stable individuals performed GXT with direct measurement of VO2. Exercise was incremented each minute to optimize clinical examination. Measured VO2max was compared to the estimated steady-state VO2 of the terminal stage based on ACSM equations. Equations for walking or running were used based on the patient's observed method of ambulation. The measured VO2max was always less than the ACSM estimate, with a regular relationship between measured and estimated VO2max. No handrail support: VO2max = 0.869.ACSM -0.07; R2 = 0.955, SEE = 4.8 ml.min-1.kg-1 (N = 30). With handrail support: VO2max = 0.694.ACSM + 3.33; R2 = 0.833, SEE = 4.4 ml.min-1.kg-1 (N = 40). The equations were cross-validated with 20 patients. The correlation between predicted and observed values was r = 0.98 and 0.97 without and with handrail support, respectively. The mean absolute prediction error (3.1 and 4.1 ml.min-1.kg-1) were similar to protocol-specific equations. We conclude that VO2max can be predicted independent of treadmill protocol with approximately the same error as protocol-specific equations.

Adult↗
PubMed2000

Legitimation of nurses' knowledge through policies and protocols in clinical practice.

Health care professionals use policies and protocols in varying ways to guide their clinical activities and to promote quality patient care. The critical ethnographic case study upon which this paper is based, involved a research group comprising six registered nurses who worked in a critical care setting. Research methods included professional journalling, participant observation, and focus group and individual interviews. This paper examines the power relations at play between doctors and nurses, and among nurses, and the ways in which nurses used policies and protocols as a means of mediating communication. While policies and protocols provided nurses with legitimacy of their knowledge in the clinical arena, doctors tended to rely on their past experience and background to inform their knowledge and activities. For nurses to believe that they provided valued and collaborative input in patient decisions, they actively sought out written evidence through policies and protocols to confirm and support their knowledge. Policies and protocols of critical care activities provided nurses with expected standards of care, which they used to legitimize their knowledge and to communicate with doctors about 'undesirable' medical decisions. The doctors valued their professional authority and autonomy over policies and protocols, while nurses used these written guidelines to assert power and demonstrate resistance. Policies and protocols do not exist in isolation; they occur within a complex network of power relations that create tensions in clinical practice. In challenging these tensions, it is important that nurses and doctors establish a fine balance between using policies and protocols to provide directions for practice, and to allow sufficient latitude and flexibility in addressing the complexities of patient care.

Clinical Protocols↗