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The authors remarked that the use of these tumor markers in mucinous epithelial tumors of the appendix has not been previously determined symptoms brain tumor cheap dramamine express. The primary endpoint was the accuracy of these two tumor markers in the management of this disease for these two specific clinical situations schedule 8 medicines generic 50mg dramamine overnight delivery. Although the absolute level of tumor marker did not correlate with prognosis symptoms low potassium cheap dramamine 50mg on-line, a normal value indicated an improved survival treatment with cold medical term cheap 50 mg dramamine. This should be a valuable diagnostic tool previously underutilized in this group of patients. These tumor markers were also of benefit in the assessment of prognosis in that a normal level indicated an improved prognosis. Andreopoulou et al (2007) stated that mucinous carcinoma of the appendix is a rare entity with a distinct natural history that poses diagnostic and therapeutic challenges and that mucinous peritoneal carcinomatosis is most commonly associated with primary tumors of the appendix and colon. Recruitment for large scale studies given the rare nature of mucinous appendiceal carcinoma would be challenging. Cathepsins this enzyme plays a critical role in protein catabolism and tissue remodeling (Chin, et al. Over-expression is associated with non ductal carcinoma and metastasis at the time of breast cancer diagnosis. Svatek et al (2008) examined the role of urinary cathepsin B and L in the detection of bladder urothelial cell carcinoma. These investigators concluded that urinary cathepsin L is an independent predictor of bladder cancer presence and invasiveness in patients with a history of urothelial carcinoma of the bladder. They stated that further evaluation of this marker is necessary before its use as an adjunct to cystoscopy for urothelial carcinoma of the bladder. This antigen is found on the surface of leukemic blasts and immature normal cells of myelomonocytic lineage, but not in normal hematopoietic stemcells. However, the specificity of these markers is such 44/512 Tumor Markers Medical Clinical Policy Bulletins | Aetna that when determined simultaneously, at least one marker will be positive in 85% of patients with active cancer. Alpha fetoprotein levels begin to decrease soon after birth and are usually undetectable in the blood of healthy adults, except during pregnancy. The rate of clearance from serum after treatment is an indicator of the effectiveness of therapy. The estrogen receptor and progesterone receptor are intracellular receptors that are measured directly in tumor tissue. These receptors are polypeptides that bind their respective hormones, translocate to the nucleus, and induce specific gene expression. Most oncologists have used the estrogen receptor and also the progesterone receptor not only to predict the probability of response to hormonal therapy at the time of metastatic disease, but also to predict the likelihood of recurrent disease, and to predict the need for adjuvant hormonal therapy or chemotherapy. Although these latter uses for estrogen and progesterone receptors are commonly accepted by most oncologists, the data on which these conclusions are based are controversial. As a 46/512 Tumor Markers Medical Clinical Policy Bulletins | Aetna result, this assay may not have high specificity or sensitivity necessary for cancer detection (Chen, et al. This serum cancer marker has not been widely accepted for use in the detection or prognosis of colorectal carcinoma. The literature on p53 abnormality and prognosis in colorectal cancer suffers from a paucity of reported data and the use of a variety of techniques in assay and statistical analysis in the small numbers of cases analyzed. For these reasons, the literature generally does not recommend p53 analysis as a routine approach to assisting in the management of patients with colorectal cancer. Guidelines from the American Society for Clinical Oncology (2016) recommend against the use of p53 to guide adjuvant chemotherapy in breast cancer. This is a moderate-strength recommendation based upon intermediate-quality evidence. Kappa / Lambda Light Chain Elevated serum levels of monoclonal free light chains are associated with malignant plasma cell proliferation. The appearance of higher levels of free light chains in the urine may be indicative of kidney disease or malignant lymphoproliferative disease such as multiple myeloma. Ras gene mutations can be found in a variety of tumor types, although the incidence varies greatly. The highest incidences are found in adenocarcinomas of the pancreas (90 %), colon (50 %), and lung (30 %); thyroid tumors (50 %), and myeloid leukemia (30 %). The mutation status of the K-ras gene in the tumor may affect the response to cetuximab and have treatment independent prognostic value. These investigators analyzed tumor samples, obtained from 394 of 572 patients (68. They evaluated if the mutation status of the K-ras gene was associated with survival in the cetuximab and supportive-care groups. The effectiveness of cetuximab was significantly associated with K-ras mutation status (p = 0. The authors concluded that patients with a colorectal tumor bearing mutated K-ras did not benefit from cetuximab, whereas patients with a tumor bearing wild-type K-ras did benefit from cetuximab. The mutation status of the K-ras gene had no influence on survival among patients treated with best supportive care alone. A total of 427 patients with metastatic colorectal cancer received either panitumumab or best supportive care. PreOvar™ may also help assess the relative risk of developing ovarian cancer for women who have a family history of ovarian cancer without a living proband (ancestor with the disease). The level of certainty of the evidence was deemed high, and the magnitude of net health benefit from 54/512 Tumor Markers Medical Clinical Policy Bulletins | Aetna avoiding potentially ineffective and harmful treatment, along with promoting more immediate access to what could be the next most effective treatment, is at least moderate. Evaluations of these patients usually entail voided-urine cytology, cystoscopy, and upper urinary tract imaging such as intravenous pyelography, renal sonography, or retrograde pyelography. Currently, urine cytology with confirmatory cystoscopy represents the cornerstone for the identification of bladder tumors. So far, no single bladder tumor marker has emerged as the generally accepted test of choice, and none has been established as a screening tool for bladder malignancy. Urine-based markers, such as proteins with increased cancer cell expression or chromosomal abnormalities in the urine, may be detected using a variety of laboratory methods to aid in the management of bladder cancer. These tests have also been proposed for bladder cancer screening, diagnosis of bladder cancer in individuals symptomatic of bladder cancer and for the evaluation of hematuria. This test is intended to augment the sensitivity of cytology for the detection of tumor cells in the urine of individuals previously diagnosed with bladder cancer. The test has been used for detection of tumor cells in the urine of individuals previously diagnosed with bladder cancer, and for use in conjunction with cytoscopy as an aid in the management of bladdercancer. Although urine cytology has been shown to be less accurate than urinary biomarker tests, familiarity with the method as well as ease of performance justify the continued routine use of the former by primary care physicians, especially in patients who have no history of bladder malignancy. The urine-based biomarker tests have been shown to be accurate in detecting low-grade bladder tumors. In particular, these tests may be of help in deciding the need for further diagnostic assessment of patients with a history of bladder cancer and negative results on urine cytology. On the other hand, consideration may be given to lengthening the intervals between cystoscopic investigations when values of these tumor markers are normal. The assessment recommended that these assays not be used in asymptomatic patients. The assessment suggested, however, that these tests may be useful in the monitoring of patients with transitional cell carcinoma between cytoscopies. An assessment prepared for the Agency for Healthcare Research and Quality (Meleth, et al. We found no studies that directly assessed the impact of a test of interest on 57/512 Tumor Markers Medical Clinical Policy Bulletins | Aetna both physician decision-making and downstream health outcomes to establish clinical utility. We attempted to construct an indirect chain of evidence to answer the overarching question, but we were unable to do so. Even in the cases where the tests seemed to add value in determining prognosis. Chou et al (2015) systematically reviewed the evidence on the accuracy of urinary biomarkers for diagnosis of bladder cancer in adults who have signs or symptoms of the disease or are undergoing surveillance for recurrent disease. For some biomarkers, sensitivity was higher for initial diagnosis of bladder cancer than for diagnosis of recurrence. Urinary biomarkers plus cytologic evaluation 58/512 Tumor Markers Medical Clinical Policy Bulletins | Aetna were more sensitive than biomarkers alone but missed about 10 % of bladder cancer cases.

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Three simple questions that may be helpful when talking with your doctor or any healthcare professional involved in your care are: • What treatment options do I havefi Your doctor may recommend one or more of the following approaches for managing pancreatic cancer symptoms 24 cheap 50mg dramamine amex. The aim of resection is to treatments yeast infections pregnant dramamine 50 mg without prescription remove the cancer along with a healthy margin of tissue to medications via g-tube buy generic dramamine 50 mg help stop it from coming back treatment trends buy generic dramamine online. However, it is important to understand that resection is possible in fewer than 20% of patients (Ducreux et al. This is because the cancer has usually already spread to other parts of the body or is affecting major blood vessels by the time it is diagnosed. Resection of tumours that have grown around major blood vessels is rarely possible as complete removal of the tumour would cause too much damage to the blood vessels. Surgery to remove the tumour is currently the only way to cure pancreatic cancer Pancreatic cancer is classifed as resectable, borderline resectable or unresectable: Resectable • Usually confned to the pancreas and surrounding regions such as the small bowel, bile duct or stomach • Not affecting any of the major blood vessels • these tumours are suitable for resection Borderline resectable • Usually confned to the pancreas area, but are affecting the blood vessels – this can make it diffcult for the tumour to be resected effectively, and some cancer cells may be left behind • It is not always clear whether the tumour can be resected or not • Detailed scans may be used to check the exact positioning of the tumour in relation to the blood vessels before a decision on resection can be reached Unresectable • Blocking or completely surrounding major blood vessels, or have spread so far that resection is not possible • Locally advanced and metastaticpancreatic cancers are unresectable Resectability of pancreatic cancer. In some patients, chemotherapy may be given as an adjuvant treatment (after resection) or as a neoadjuvant treatment (before resection) (Ducreux et al. Some patients may not be well enough to tolerate treatment with certain chemotherapy regimens, so your doctor will take your general health and ftness into consideration when deciding on the best treatment for you. You may have heard of new drugs for pancreatic cancer – ask your doctor about these and about participating in clinical trials (see section ‘Clinical trials’ for more information). Chemotherapy is widely used in the treatment of pancreatic cancer Chemoradiotherapy Chemoradiotherapy is a combination of chemotherapy and radiotherapy. Treatment for resectable pancreatic cancer typically involves resection of the tumour, followed by adjuvant chemotherapy. Surgery the aim of surgical resection is to remove the cancer as well as a healthy margin of tissue around it. After the operation, the removed tissue is examined under a microscope to check that all of the cancer was removed. Tumours in the pancreatic head are removed using a technique called a pancreatoduodenectomy (also known as the Whipple procedure). In a pancreatoduodenectomy, the head of the pancreas is removed along with the duodenum, gallbladder, part of the stomach and part of the bile duct. Tumours in the pancreatic body or tail are removed by distal pancreatectomy, which involves resection of the body and tail of the pancreas as well as the spleen (Ducreux et al. During resection of the tumour, lymphadenectomy (removal of nearby lymph nodes) is also carried out. A minimum of 15 lymph nodes are removed and examined after the operation to see if the cancer has spread (Ducreux et al. Another clinical trial has also indicated that adjuvant treatment with gemcitabine in combination with capecitabine might be more effective than gemcitabine alone (Neoptolemos et al. Treatment for borderline resectable pancreatic cancer aims to reduce the size of the tumour using chemotherapy and chemoradiotherapy, potentially making resection possible. Chemotherapy Borderline resectable pancreatic cancer may be initially treated with neoadjuvant chemotherapy. However, patients with borderline resectable tumours are included in clinical trials whenever possible, so other neoadjuvant treatments may be offered (see section ‘Clinical trials’ for more information) (Ducreux et al. Chemoradiotherapy Following the period of neoadjuvant chemotherapy, patients may have a course of chemoradiotherapy to help try to convert the tumour from borderline resectable to resectable (Ducreux et al. Initial treatment for borderline resectable pancreatic cancer aims to reduce the size of the tumour and make it resectable Surgery After neoadjuvant treatment with chemotherapy and chemoradiotherapy, the tumour will be re assessed to see if it is now resectable. Patients with tumours that are resectable will undergo surgery, possibly followed by adjuvant chemotherapy (see section ‘What are the treatment options for resectable pancreatic cancerfi Locally advanced pancreatic cancer is unresectable and is usually treated with chemotherapy. Chemotherapy the usual treatment for locally advanced pancreatic cancer is gemcitabine (Ducreux et al. Other treatments might be offered in clinical trials (see section ‘Clinical trials’ for more information). Chemoradiotherapy Chemoradiotherapy may be offered to some patients with locally advanced pancreatic cancer, but this is less common in Europe (Ducreux et al. The aim of treatment for metastatic pancreatic cancer is to relieve symptoms and improve quality of life. Chemotherapy the choice of chemotherapy for metastatic pancreatic cancer varies depending on the general health status of the patient. Patients who are less ft may be offered gemcitabine alone, or nab-paclitaxel plus gemcitabine if their poor health status is due to their cancer. Chemotherapy is the standard treatment for metastatic pancreatic cancer, but not all drugs are suitable for all patients Some patients will be unable to tolerate treatment with chemotherapy, and these patients will be offered supportive care rather than chemotherapy (see section ‘Supplementary interventions’ for more information). Research is ongoing to identify new drugs, or different combinations of existing drugs, to improve the prognosis for patients. Clinical trials help to improve knowledge about cancer and develop new treatments, and there can be many benefts to taking part. You would be carefully monitored during and after the study and the new treatment may offer benefts over existing therapies. It’s important to bear in mind, however, that some new treatments are found not to be as good as existing treatments or to have side effects that outweigh the benefts (ClinicalTrials. Clinical trials help to improve knowledge about diseases and develop new treatments – there can be many benefts to taking part Several new drugs for the treatment of pancreatic cancer are now entering clinical trials, including immunotherapy agents, which stimulate the body’s immune system to fght cancer cells. You have the right to accept or refuse participation in a clinical trial without any consequences for the quality of your treatment. If your doctor does not ask you about taking part in a clinical trial and you want to fnd out more about this option, you can ask your doctor if there is a trial for your type of cancer taking place nearby (ClinicalTrials. These interventions may include supportive, palliative, survivorship and end-of-life care, which should all be coordinated by a multidisciplinary team (Jordan et al. Patients may fnd that supportive care helps them to cope with their diagnosis, treatment and the long-term effects of pancreatic cancer Supportive care Supportive care involves the management of cancer symptoms and the side effects of therapy. An important element of supportive care in patients with pancreatic cancer is nutritional support – many people with pancreatic cancer lose weight as the tumour, or effects from surgery, can have an impact on the stomach and bowel. A dietician will be able to advise you on your diet and any supplements that you might need. You may fnd it easier to have small, high-calorie snacks throughout the day rather than large meals, and your dietician may also recommend nutritional supplements tailored to your needs. Patients with pancreatic cancer may also be unable to absorb fats and proteins from their food – this is because the pancreas is not producing enough digestive enzymes, either because of the cancer itself, or because parts of the pancreas have been removed during treatment. This is called pancreatic exocrine insuffciency and you may need to take enzyme supplements before each meal to help your body digest food properly (Vujasinovic et al. Supportive care includes help with diet and nutrition Tumours in the pancreas, or surgery for pancreatic cancer, can also affect the production of insulin, which is a hormone that regulates blood sugar levels. Some patients will have to test their own blood sugar levels and have insulin injections. This can be easily learned and a trained specialist nurse should be available to support you. Palliative care in pancreatic cancer can often include a procedure to relieve the symptoms of a tumour obstructing the bile duct or duodenum. This is usually done by inserting a specially-designed expandable tube (or stent) under general anaesthetic to keep the bile duct or duodenum open (Ducreux et al. Pain relief is also an important part of palliative care in patients with pancreatic cancer. There are a number of pain relief options available to patients with pancreatic cancer, which your doctor will discuss with you. In addition to standard painkillers such as paracetamol and ibuprofen, drugs called opioids are often used, and some anti-depressants or anti-convulsant drugs are used alongside other painkillers to control nerve pain. A procedure called coeliac plexus block is sometimes used to relieve pain in the abdomen – this involves an injection of local anaesthetic around a group of nerves called the coeliac plexus, and can provide pain relief for up to 3 months (Ducreux et al. This is a process that helps patients to understand the course of cancer, provides counselling and encourages them to consider their wishes for their care. The overall aim of advance care planning is to enable patients to make informed decisions that will allow them to receive the best care suited to their personal, cultural, spiritual and moral wishes (Agarwal and Epstein, 2017).

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If such a progression is rapid and associated with significant weight loss symptoms internal bleeding dramamine 50mg line, a malignant stricture is suspected medicine 9 minutes 50mg dramamine with mastercard. For instance medications joint pain generic 50mg dramamine with amex, a reflux-induced stricture should be suspected if the dysphagia is associated with heartburn or regurgitation medications ending in zine dramamine 50mg low price, esophageal cancer if there is associated mid-back pain and weight loss, a motor disorder such as diffuse esophageal spasm if there is angina-like chest pain, and a “scleroderma esophagus” if there is arthralgia, skin changes or Raynaud’s phenomenon. When the pain is retrosternal, one should suspect nonreflux-induced forms of esophagitis, such as infection, radiation or pill-induced (chemical) injury. It may be precipitated by bending over or lying down, and usually begins shortly after consuming certain foods or beverages. It is often associated with First Principles of Gastroenterology and Hepatology A. This very common symptom has been experienced at one time or another by over one-third of the population and therefore does not necessarily indicate serious disease. Many patients will complain of “heartburn,” but this should not be taken at face value: this term is used by some patients to describe unrelated symptomatology. It is therefore important to have patients describe exactly what they mean by the term heartburn. Regurgitation this refers to the spontaneous appearance of food or fluid in the back of the throat or in the mouth. Some patients describe this symptom as “vomiting”; therefore it is important to determine whether there is associated nausea, retching, etc. Regurgitation of undigested food or stagnant fluid devoid of an acidic taste indicates an esophageal transport problem. Some patients regurgitate food back into their mouths after a meal only to chew and swallow it all over again. This is called rumination and, although a rarity in humans, it is a normal physiological event in certain animals. Chest pain, and in particular mid dorsal pain, is seen in advanced esophageal cancer. The most common type of nonheartburn esophageal chest pain, however, is a pain that is qualitatively similar to the pain of ischemic heart disease (so-called “noncardiac chest pain”). Unlike ischemic heart pain, angina-like chest pain of esophageal origin is not predictably elicited by exertion and often occurs spontaneously, in relationship to meals or in the middle of the night. Clearly, patients with this type of pain need to have ischemic heart disease excluded. Once this is done, many will be found to have either gastroesophageal reflux or some form of esophageal motor or sensory disorder. Waterbrash the sudden appearance of copious amounts of saliva in the mouth must be differentiated from regurgitation of fluid. With waterbrash, acid reflux into the esophagus stimulates hypersalivation via a (cholinergic) neural reflex. Mucosal laceration in the region of the gastroesophageal junction (Mallory-Weiss tear), as a consequence of retching or vomiting, is a common cause of upper gastrointestinal tract bleeding. Usually the bleeding from ulcerative lesions of the esophagus or esophageal cancer is occult. When the patient does present with hematemesis or melena from esophagitis, the rate of bleeding is usually slow; therefore, significant hemodynamic compromise is uncommon. Respiratory/Laryngeal Symptoms these may be a manifestation of esophageal disease or oropharyngeal swallowing disorders. Aspiration at the time of swallowing will cause coughing, choking and eventual hoarseness. These patients may present with pneumonia, chronic cough, wheezing, hoarseness or laryngitis. Gastroesophageal reflux might also trigger coughing and wheezing via a vagovagal reflex. Signs It is uncommon for esophageal disease to be associated with specific physical findings. Signs of weight loss and malnutrition can be found if the esophageal problem is so severe that adequate caloric intake is not maintained. It is important to look for signs of connective tissue disease (especially scleroderma) in patients with reflux symptoms or dysphagia. The physical examination is more often helpful in patients with oropharyngeal dysphagia. Careful examination of the head and neck for structural and neurologic abnormalities is mandatory. It is also important to look for more generalized neurologic or connective tissue abnormalities. Observing the patient swallow is also useful when oropharyngeal dysphagia is present. Investigations Used in the Diagnosis of Esophageal Disease A number of tests are available to facilitate the diagnosis of patients with suspected esophageal disease. The choice of which diagnostic test to use depends on the patient presentation and the question(s) to be answered. Barium X-ray this most commonly used method of investigating the esophagus evaluates both structural lesions and motor disorders. Videotaping the barium swallow (“video-fluoroscopy swallowing study”) allows for playback and slow-motion review. This is very helpful in assessing the rapid events of the oropharyngeal phase of swallowing. Use of marshmallows, barium-coated cookies and different consistencies of barium further assesses swallowing disorders, as delays in transport may not be apparent with simple liquid barium. The disadvantage of barium x-rays is that they are relatively insensitive in detecting mucosal disease. If a patient is suspected of having an esophageal perforation, a water soluble contrast agent (Gastrograffin) should be used in place of barium. Endoscopy with Mucosal Biopsy and Brush Cytology Fiberoptic endoscopy directly visualizes the esophageal mucosa as well as other areas of the upper gastrointestinal tract. Its direct view is superior to barium x-rays for assessing mucosal disease of the esophagus. Furthermore, pinch biopsies and/or brush cytology of specific lesions are easily obtained through the endoscope. Microscopic evidence of esophagitis may be found even when the mucosa looks grossly normal. Endoscopy is the single most useful test in the evaluation of patients with reflux symptoms, as it permits one to establish the presence or First Principles of Gastroenterology and Hepatology A. Endoscopic Ultrasound this technique combines ultrasonography with endoscopy by placing an ultrasound transducer at the end of a video endoscope. It is particularly useful in staging esophageal cancer in that it is the most sensitive imaging technique for determining the depth of invasion through the esophageal wall and involvement of region lymph nodes. Endoscopic view of normal distal esophagus (left) and from a patient with reflux esophagitis (right). Note linear superficial ulcerations with normal appearing esophageal mucosa in between. Esophageal Manometry this involves recording intraluminal pressures at multiple sites along the esophagus (Figure 1). The most commonly used method involves a perfused multilumen catheter bundle with side holes at 5 cm intervals. Each catheter is connected to a pressure transducer, which in turn is attached to a physiograph. Esophageal manometry is the “gold standard” in the assessment of esophageal motor disorders. Motor dysfunction, however, may be intermittent and therefore not detected at the time of the study. Manometry may be combined with provocative tests (acid perfusion, balloon distention and/or pharmacological stimulation of the esophagus with bethanechol or edrophonium) in an attempt to evoke abnormal contractions and reproduce the patient’s chest pain (Section 11). In recent years, the introduction of “high resolution” manometry has allowed for more detailed recording and analysis of esophageal motor function. Using multiple pressure sensors spaced at 1 cm intervals, the pressure profile from pharynx to stomach can be assessed simultaneously. Sophisticated software converts the data to contour plots using different colours to depict pressure variations, thereby facilitating detection of motor disorders. The technique can be combined with simultaneous intraluminal impedance recording, so that bolus transit can be simultaneously measured and correlated with motor function. This powerful methodology enhances the detection of esophageal motor disorders, but is quite expensive.

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Examples of adverse events may include surgical site infection symptoms magnesium deficiency buy dramamine 50mg with visa, deep vein thrombosis medications memory loss discount dramamine 50mg amex, or pulmonary embolism medications given to newborns discount dramamine 50mg visa. C10–Restraint Use Whenever restraints are used treatment kitty colds 50mg dramamine free shipping, review the documented reasons and evaluate the possible relationship between the use of restraints and confusion from drugs, etc. C11–Healthcare-Associated Infections Any infection occurring after admission to the hospital is likely an adverse event, especially those related to procedures or devices. Infections that cause admission to the hospital should be reviewed to determine whether they are related to medical care. C12–In-Hospital Stroke Evaluate the cause of the stroke to determine whether it is associated with a procedure. When procedures or treatments have likely contributed to a stroke, this is an adverse event. C13–Transfer to Higher Level of Care Transfers to a higher level of care within the institution, to another institution, or to your institution from another must be reviewed. All transfers are likely to be the result of an adverse event and a patient’s clinical condition may have deteriorated secondary to an adverse event. A higher level of care may include telemetry, intermediate care, or a step-down unit if the patient is transferred from a general medical or surgical nursing unit. C14–Any Procedure Complication A complication resulting from any procedure is an adverse event. Procedure notes frequently do not indicate the complications, especially if they occur hours or days after the procedure note has been dictated, so watch for complications noted in coding, the discharge summary, or other progress notes. M4–Glucose Less than 50 mg/dl Review for symptoms such as lethargy and shakiness documented in nursing notes, and the administration of glucose, orange juice, or other intervention. If symptoms are present, look for associated use of insulin or oral hypoglycemics. If a change of two times greater than baseline levels is found, review medication administration records for medications known to cause renal toxicity. Review physician progress notes and the history and physical for other causes of renal failure, such as pre-existing renal disease or diabetes, that could have put the patient at greater risk for renal failure; this would not be an adverse event, but rather the progression of disease. An adverse event has likely occurred if there are laboratory reports indicating a drop in hematocrit or guiac-positive stools. If the drug has been administered, review the record to determine if it was ordered for symptoms of an allergic reaction to a drug or blood transfusion administered either during the hospital ization or prior to admission—these are adverse events. M8–Romazicon (Flumazenil) Administration Romazicon reverses the effect of benzodiazepine drugs. Usage likely represents an adverse event except in cases of drug abuse or self-inflicted overdose. M10–Anti-Emetic Administration Nausea and vomiting commonly are the result of drug administrations both in surgical and non-surgical settings. Nausea and vomiting that interferes with feeding, post-operative recovery, or delayed discharge suggests an adverse event. One or two episodes treated successfully with anti-emetics would suggest no adverse event. M11–Over-Sedation/Hypotension Review the physician progress, nursing, or multidisciplinary notes for evidence of over sedation and lethargy. Review vital signs records or graphics for episodes of hypotension related to the administration of a sedative, analgesic, or muscle relaxant. M12–Abrupt Medication Stop Although the discontinuation of medications is a common finding in the record, abruptly stopping medications is a trigger requiring further investigation for cause. A sudden change in patient condition requiring adjustment of medications is often related to an adverse event. M13–Other Use this trigger for adverse drug events detected but not related to one of the Medication triggers listed above. Surgical Module Triggers S1–Return to Surgery A return to the operating room can either be planned or unplanned, and both can be a result of an adverse event. An example of an adverse event would be a patient who had internal bleeding following the first surgery and required a second surgery to explore for the cause and to stop the bleeding. Even if the second surgery is exploratory but reveals no defect, this should be considered an adverse event. S2–Change in Procedure When the procedure indicated on the post-operative notes is different from the procedure planned in the pre-operative notes or documented in the surgical consent, a reviewer should look for details as to why the change occurred. An unexpected change in procedure due to complications or device or equipment failure should be considered an adverse event, particularly if length of stay increases or obvious injury has occurred. S3–Admission to Intensive Care Post-Operatively Admission to an intensive care unit can be either a normal post-operative journey or it may be unexpected. For example, admission to intensive care following aortic aneurysm repair may be expected, but admission following knee replacement would be unusual. S5–X-Ray Intra-Operatively or in Post Anesthesia Care Unit Imaging of any kind that is not routine for the procedure requires investigation. An x-ray taken due to suspicion of retained items or incorrect instrument or sponge count would be a positive trigger. The identification of a retained item necessitating an additional procedure is an adverse event. If the retained item is identified and removed without any additional evidence of harm or re-operation to the patient, this is not considered an adverse event. S6–Intra or Post-Operative Death All deaths that occur intra-operatively should be considered adverse events unless death is clearly expected and the surgery was of a heroic nature. Post-operative deaths will require review of the record for specifics, but in general all post-op deaths will be adverse events. If the patient requires mechanical ventilation beyond 24 hours, an intra-operative or post-operative adverse event should be considered. Patients with pre-existing pulmonary or muscular disease may experience more difficulty in quickly weaning from a ventilator post-operatively, but this should not automatically exclude the possibility of an adverse event. Reviewers must use clinical judgment to determine whether the intra-operative and post-operative care was event free or part of the disease process. S8–Intra-Operative Administration of Epinephrine, Norepinephrine, Naloxone, or Romazicon these medications are not routinely administered intra-operatively. Hypotension caused by bleeding or over-sedation are examples of adverse events that might be treated with these medications. Reviewers will need to use clinical judgment as to whether a cardiac event has occurred. S10–Injury, Repair, or Removal of Organ During Operative Procedure Review operative notes and post-operative notes for evidence that the procedure included repair or removal of any organ. The removal or repair must be part of the planned procedure or this is an adverse event and likely the result of surgical misadventure such as an accidental injury. If the evidence suggests the pneumonia started prior to admission to the hospital, there is no adverse event; but if the review suggests initiation in the hospital, it is an adverse event. In general, any infection starting in not only the intensive care unit but in any hospital unit will be considered nosocomial. Readmissions either to the hospital or the intensive care unit could represent a nosocomial infection from a previous hospitalization. I2–Readmission to the Intensive Care Unit Refer to trigger S3–Admission to Intensive Care Post-Operatively. Complications will commonly not be on the dictated procedure note, but may be evident by the care required, which might indicate an event has occurred. I4–Intubation/Reintubation Refer to trigger S4–Intubation or Reintubation or Use of BiPap in Post Anesthesia Care Unit. P1–Terbutaline Use Use of terbutaline could result in an unnecessary intervention of a cesarean section that is created by the administration of a medication. P2–3rd or 4th-Degree Lacerations By definition a 3rd or 4th-degree laceration is an adverse event. Also look for additional events to the mother or child associated with the laceration as part of a cascade so appropri ate severity can be assessed. P3–Platelet Count Less than 50,000 Look for adverse events related to bleeding such as strokes, hematomas, and hemorrhage requiring blood transfusions.

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