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By: F. Grimboll, M.B. B.CH. B.A.O., M.B.B.Ch., Ph.D.
Clinical Director, Sanford School of Medicine of the University of South Dakota
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The research study is sponsored by an organization or individual capable of executing the proposed study successfully. All aspects of the research study are conducted according to appropriate standards of scientific integrity (see. The research study pro to col specifies the method and timing of public release of all pre-specified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. If a report is planned to be published in a peer-reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Edi to rs. However a full report of the outcomes must be made public no later than 3 years after the end of data collection. The research study pro to col explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention. The rationale for the study is well supported by available scientific and medical evidence. The study is sponsored by an organization or individual capable of completing it successfully. All aspects of the study are conducted according to appropriate standards of scientific integrity. The study pro to col must explicitly discuss beneficiary subpopulations affected by the item or service under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations in the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the pro to col must discuss why these criteria are necessary. Other All other indications for stem cell transplantation not otherwise noted above as covered or non-covered remain at local Medicare Administrative Contrac to r discretion. Inpatient Hospital Stay for Alcohol De to xification Many hospitals provide de to xification services during the more acute stages of alcoholism or alcohol withdrawal. This limit (five days) may be extended in an individual case where there is a need for a longer period for de to xification for a particular patient. In such cases, however, there should be documentation by a physician which substantiates that a longer period of de to xification was reasonable and necessary. Following de to xification a patient may be transferred to an inpatient rehabilitation unit or discharged to a residential treatment program or outpatient treatment setting.
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However, to avoid redundancy, each of the publications is reviewed here, with a focus on the methods used. In Yi (2013), a to tal of 185,265 Korean men, who had served in Vietnam from 1964 to 1973 and who were alive in 1992 were followed for cancer inci dence from 1992 to 2003. Cancer diagnoses were ascertained via linkage with the Korean National Cancer Incidence Database, whereas cancer deaths were identifed using National Statistical Offce records. Age-adjusted incidence and standardized incidence ratios were calculated using the Korean male population during 1992 to 2003 as the reference population (Yi, 2013). The overall cancer incidence among Vietnam veterans was not higher than in the general male population. However, when the incidence was analyzed by cancer type, Vietnam veterans and subgroups of the study population classifed by military rank (enlisted; non-commissioned offcer; offcer) experienced a higher incidence of several cancers, including prostate cancer, T-cell lymphoma, lung cancer, bladder cancer, kidney cancer, and colon cancer, than the general Korean population. Associations were reported between self-reported diseases and high versus low exposures. All disease outcomes were based on self-report and classifed in to seven groups of diseases: cancers, circula to ry diseases, respira to ry diseases, digestive diseases, neuromuscular diseases, endocrine diseases, and other dis eases. The Update 2014 committee was concerned about the reliability of self-reported exposure and health data because the use of such data in Yi et al. The observation of inconsisten cies when theoretically more reliable measures of health and exposure were analyzed reinforced the concern about the fndings based on self-report in the Korean study. The incidence of cancer was determined through a review of records from the Korea National Cancer Incidence Database. Compared with low exposure, high herbicide exposure appeared to be most related to an elevated risk of can cers of the mouth, salivary glands, s to mach, and small intestine. The objective classifcation of both herbicide exposure and cancer incidence is considered a strength of this study over other publications from this cohort that used self-report data for analyses. Health information was derived through a review of claims data from the Health Insurance Review and Assessment Service of Korea from January 1, 2000, to September 30, 2005. Overall, and compared with low exposure, high herbicide exposure was associated with a statistically signifcantly higher preva lence of hypothyroidism, au to immune thyroiditis, other endocrine gland disorders including pituitary gland disorders, as well as amyloidosis and Alzheimer disease. As with Yi and Ohrr (2014), the objective classifcation of both herbicide expo sure and disease prevalence is considered a strength of this study.
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Twenty were treated after surgery with 18 of these exhibiting positive margins or gross residual disease. Longer follow-up is needed to gauge the durability of disease control and to moni to r for late to xicities of therapy. Sites of treatment included lacrimal gland or sac (5), paranasal sinus (4), parotid gland (4), submandibular gland (2) and buccal mucosa (1). Median dose delivered was 60 Gy with 12 patients receiving concurrent chemotherapy. Four patients developed acute grade 3 to xicity and one patient experienced a grade 4 to xicity (blindness). An additional patient developed asymp to matic frontal lobe necrosis 18 months after treatment completion with near resolution at 24 months. One additional patient refused radiation and chemotherapy after surgery but received stereotactic radiosurgery at the time of recurrence. Patients had stage T1N0 (1), T2N0 (6), T3N0 (1) or T4N0 (3), all without metastases. Primary sites included the lacrimal gland (7), lacrimal sac/nasolacrimal duct (10) or eyelid (3). Seven patients experienced acute grade 3 while 9 patients developed chronic grade 3 ocular or eyelid function to xicity. Bivariate analysis revealed that a dose of 36 Gy or less to the ipsilateral cornea was associated with grade 3 chronic ocular to xicity (p = 0. Additional data are needed to identify which patients are most likely to benefit from aggressive efforts to achieve local disease control and to evaluate the potential benefit of pro to n therapy relative to other modalities of reirradiation. Page 49 of 272 Lee et al. All plans were calculated to 55 Gy in 25 fractions with equivalent constraints and normalized to prescription dose. Pro to ns also increased generalized equivalent uniform dose to duodenum and s to mach, however these differences were small (< 5% and 10%, respectively; p < 0.
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Intra-abdominal hemorrhage Medical intervention or minor Transfusion, radiologic, Life-threatening Death cauterization indicated endoscopic, or elective consequences; urgent operative intervention intervention indicated indicated Definition: A disorder characterized by bleeding in the abdominal cavity. Mucositis oral Asymp to matic or mild Moderate pain; not interfering Severe pain; interfering with Life-threatening Death symp to ms; intervention not with oral intake; modified diet oral intake consequences; urgent indicated indicated intervention indicated Definition: A disorder characterized by inflammation of the oral mucosal. Rectal hemorrhage Mild; intervention not indicated Moderate symp to ms; medical Transfusion, radiologic, Life-threatening Death intervention or minor endoscopic, or elective consequences; urgent cauterization indicated operative intervention intervention indicated indicated Definition: A disorder characterized by bleeding from the rectal wall and discharged from the anus. Tooth discoloration Surface stains Definition: A disorder characterized by a change in to oth hue or tint. General disorders and administration site conditions General disorders and administration site conditions Grade Adverse Event 1 2 3 4 5 Chills Mild sensation of cold; Moderate tremor of the entire Severe or prolonged, not shivering; chattering of teeth body; narcotics indicated responsive to narcotics Definition: A disorder characterized by a sensation of cold that often marks a physiologic response to sweating after a fever. Neck edema Asymp to matic localized neck Moderate neck edema; slight Generalized neck edema edema obliteration of ana to mic. Hepatic hemorrhage Mild; intervention not indicated Symp to matic; medical Transfusion indicated Life-threatening Death intervention indicated consequences; urgent intervention indicated Definition: A disorder characterized by bleeding from the liver. Hepatic necrosis Life-threatening Death consequences; urgent radiologic or operative intervention indicated Definition: A disorder characterized by a necrotic process occurring in the hepatic parenchyma. Immune system disorders Immune system disorders Grade Adverse Event 1 2 3 4 5 Allergic reaction Transient flushing or rash, Intervention or infusion Prolonged. Symp to ms include fever, arthralgias, myalgias, skin eruptions, lymphadenopathy, chest marked discomfort and dyspnea. Joint infection Localized; local intervention Arthroscopic intervention Life-threatening Death indicated; oral intervention indicated. Burn Minimal symp to ms; Medical intervention; minimal Moderate to major Life-threatening Death intervention not indicated debridement indicated debridement or reconstruction consequences indicated Definition: A finding of impaired integrity to the ana to mic site of an adverse thermal reaction. The extent of damage depends on the length and intensity of exposure and time until provision of treatment. Fallopian tube anas to motic Asymp to matic; clinical or Symp to matic; medical Severe symp to ms; radiologic, Life-threatening Death leak diagnostic observations only; intervention indicated endoscopic or elective consequences; urgent intervention not indicated operative intervention operative intervention indicated indicated Definition: A finding of leakage due to breakdown of a fallopian tube anas to mosis (surgical connection of two separate ana to mic structures). Gastrointestinal s to ma Superficial necrosis; Severe symp to ms; Life-threatening Death necrosis intervention not indicated hospitalization or elective consequences; urgent operative intervention intervention indicated indicated Definition: A finding of a necrotic process occurring in the gastrointestinal tract s to ma. Intraoperative gastrointestinal Primary repair of injured Partial resection of injured Complete resection or Life-threatening Death injury organ/structure indicated organ/structure indicated reconstruction of injured consequences; urgent organ/structure indicated; intervention indicated disabling Definition: A finding of damage to the gastrointestinal system during a surgical procedure. Intraoperative venous injury Primary repair of injured Partial resection of injured Complete resection or Life-threatening Death organ/structure indicated organ/structure indicated reconstruction of injured consequences; urgent organ/structure indicated; intervention indicated disabling Definition: A finding of damage to a vein during a surgical procedure. Pos to perative thoracic Extubated within 24 72 hrs Extubated >72 hrs Life-threatening airway Death procedure complication pos to peratively pos to peratively, but before compromise; urgent tracheos to my indicated intervention indicated. Prolapse of uros to my Asymp to matic; clinical or Local care or maintenance; Dysfunctional s to ma; elective Life-threatening Death diagnostic observations only; minor revision indicated operative intervention or major consequences; urgent intervention not indicated s to mal revision indicated intervention indicated Definition: A finding of displacement of the uros to my.
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