4 resultados para good clinical practice
em DigitalCommons@The Texas Medical Center
Resumo:
Purpose: To evaluate the clinical impact of the Varian Exact Couch on dose and volume coverage to targets and critical structures and tumor control probability (TCP) for 6-MV IMRT and Arc Therapy. Methods: Five clinical prostate patients were planned with both, 6-MV 8-field IMRT and 6-MV 2-field RapidArc using the Eclipse treatment planning system (TPS). These plans neglected treatment couch attenuation, as is standard clinical practice. Dose distributions were then recalculated in Eclipse with the inclusion of the Varian Exact Couch (imaging couch top) and the rails in varying configurations. The changes in dose and coverage were evaluated using the DVHs from each plan iteration. We used a tumor control probability (TCP) model to calculate losses in tumor control resulting from not accounting for the couch top and rails. We also verified dose measurements in a phantom. Results: Failure to account for the treatment couch and rails resulted in clinically unacceptable dose and volume coverage losses to the target for both IMRT and RapidArc. The couch caused average dose losses (relative to plans that ignored the couch) to the prostate of 4.2% and 2.0% for IMRT with the rails out and in, respectively, and 3.2% and 2.9% for RapidArc with the rails out and in, respectively. On average, the percentage of the target covered by the prescribed dose dropped to 35% and 84% for IMRT (rails out and in, respectively) and to 18% and 17% for RapidArc (rails out and in, respectively). The TCP was also reduced by as much as 10.5% (6.3% on average). Dose and volume coverage losses for IMRT plans were primarily due to the rails, while the imaging couch top contributed most to losses for RapidArc. Both the couch top and rails contribute to dose and coverage losses that can render plans clinically unacceptable. A follow-up study we performed found that the less attenuating unipanel mesh couch top available with the Varian Exact couch does not cause a clinically impactful loss of dose or coverage for IMRT but still causes an unacceptable loss for RapidArc. Conclusions: Both the imaging couch top and rails contribute to dose and coverage loss to a degree that, if included, would prevent the plan from meeting clinical planning criteria. Therefore, the imaging and mesh couch tops and rails should be accounted for in Arc Therapy and the imaging couch and rails only in IMRT treatment planning.
Resumo:
The level of compliance with clinical practice guidelines for patients with Type II Diabetes Mellitus was evaluated in 157 patients treated at BAMC from 1 January 2006 to 1 January 2007. This retrospective analysis was conducted reviewing data from medical records and following the VA/DOD protocols that health care providers are expected to follow at this facility. Data collected included patient’s age and gender, presence or absence of complications of diabetes, physical examination findings, glycemic and lipid control, eye care, foot care, kidney function, and self-management and education. Subjects were selected performing systematic random sampling, and included both male and female patients, from a variety of ages and ethnic groups. The Diabetes complications screened for included glycemic and lipid complications, retinopathy, cardiovascular complications, peripheral circulation complications, and nephropathy. The results revealed that 19.10% had no complications and that the most common complications were: cardiovascular (49.68%), glycemic and lipid control (10.82%), retinopathy and peripheral circulation (8.28% each), and nephropathy (2.54%). Only 2.54% of the records reviewed did not include information on complications. Strictly following the Department of Defense guidelines, six treatment modules were evaluated independently and together to get a final percentage of adherence to the clinical practice guidelines. It was established that the level of adherence was going to be graded as follows: Extremely deficient: 0-15%; very poor: 16-30%; Poor and in need of improvement: 31-45%. Acceptable: 46-60%; Good: 61-80%, and Excellent: 81-100%. The results indicated that the percentage of physicians' adherence to each protocol was as follows: 88.31%, 89.93%, 90.63%, 89.42%, 89.42% and 89.64%. When the results were pooled, the level of adherence to the clinical practice guidelines was 89.55%, proving my hypothesis that Brooke Army Medical Center physicians have excellent adherence to the standard protocols for Diabetes Type II to treat their patients. ^
Resumo:
Background: The Institute of Medicine estimates that only a maximum of 25% of clinical research findings are incorporated into practice by physicians. To improve clinical practice, efforts have been made to promote evidence-based medicine and the use of clinical guidelines. Despite these efforts, the gap between research and clinical practice remains wide.^ Objective: To systematically review the literature describing the factors which influence the use of clinical research recommendations by American physicians.^ Hypothesis: Barriers exist in the application of clinical research into clinical practice, and are multifactorial. The establishment of the Clinical and Translational Awards (CTSA; special federal grants awarded to selected institutions to support clinical and translational research) has reduced the effect of these barriers and improved the process of clinical research translation into practice among American physicians.^ Aims: Identify barriers and facilitators of the use of research findings in clinical practice by American physicians. Contrast studies published six years before and after the creation of the CTSA.^ Methods: The sources of data include published literature from Medline, PubMed and PsycINFO. Selected studies must be qualitative, a survey of American clinicians, based on evidence-based medicine practice, clinical guidelines or treatment pathways. Systematic reviews and reports were excluded, as well as studies with less than 100 respondents.^ Results: In total, 1036 abstracts were reviewed; 115 full text potential articles were identified and reviewed, and a total of 31 studies met all criteria for inclusion in the final review.^ Conclusions: The barriers against the application of clinical research findings, in the forms of clinical guidelines, evidence-based medicine guides and clinical pathways, can be divided broadly into physician barriers, practice/system barriers and patient barriers. Physician barriers are the most common barriers, especially the lack of familiarity with guidelines and the lack of time. Of the factors which improve the use of research based guidelines, physician factors such as younger age, lower duration of clinical practice, specialty training, and practice in large group Health Maintenance Organization (HMO) settings with fewer patients seen were the most commonly cited.^
Resumo:
Background: In the United States, the Food and Drug Administration (FDA) regulates clinical trials. These regulations address good clinical practices as well as human subject protection (FDA, 2012). One of the most important legal and ethical concerns in clinical trials is informed consent. 21 CFR 50 governs human subjects research. Part 50.24 provides an emergency research exception to the informed consent requirement. Research was conducted to determine the appropriateness of this exception, whether the benefit justifies the exception, and its public health significance.^ Methods: A systematic literature review was conducted and articles were identified from peer-reviewed journals.^ Results: There is some variance in opinions regarding the appropriateness of the exception, but the literature reviewed found the study results of these trials justified the waiver.^ Conclusion: The exception to the informed consent requirement is likely appropriate and justified in emergency research when implemented within the specified guidelines.^