When a resident is transferred arteria differential buy 40mg sotalol with mastercard, the information provided to the receiving provider must include special instructions or precautions for ongoing care and other necessary information including a discharge summary heart attack diet sotalol 40 mg with mastercard. Process Surveillance 52 Process surveillance is the review of practices by staff directly related to resident care hypertension treatment guidelines 2014 best sotalol 40mg. Some areas that facilities may want to consider for process surveillance are the following: Surveillance definitions of infections in long-term care facilities: Revisiting the McGeer criteria blood pressure varies buy sotalol with amex. Outcome Surveillance Another component of a system of identification is outcome surveillance blood pressure chart dental treatment order sotalol on line amex. This process consists of collecting/documenting data on individual resident cases and comparing the collected data to standard written definitions (criteria) of infections blood pressure meaning generic sotalol 40mg without prescription. The following are some sources of data that can be utilized in outcome surveillance for infections heart attack 40 year old male 40mg sotalol fast delivery, antibiotic use and susceptibility: Monitoring a resident(s) with fever or other signs or symptoms suspicious for infection; blood pressure chart vs age order sotalol amex. The facility must identify how reports will be provided to staff and/or prescribing practitioners in order to revise interventions/approaches and/or re-evaluate medical interventions related to the infection rates and outcomes. An outbreak is the occurrence of more cases than expected in a given area or among a specific group of 53 people over a particular period of time. If a condition is rare or has serious health implications, an outbreak may involve only one case. While a single case of a rare infectious condition or one that has serious health implications may or may not constitute an outbreak, facilities should not wait for the definition of an outbreak to act. For example, one case of laboratory confirmed influenza in a resident should alert the facility to begin an outbreak 54 investigation. Healthcare staff and resident care equipment often move from resident to resident and therefore may serve as a vehicle for transferring infectious organisms. In nursing homes, resident-to-resident direct contact transmission may occur in common areas of the facility such as the recreation room, rehabilitation area, and/or dining room. Indirect Contact Transmission: involves the transfer of an infectious agent through a contaminated inanimate object or person. Certain pathogens may contaminate and survive on equipment and environmental surfaces for long periods of time. Mechanisms to prevent and control transmission of infectious organisms through direct and indirect contact include standard and transmission-based precautions and are described in their subsequent sections. These evidence-based practices are designed to protect healthcare staff and residents by preventing the spread of infections among residents and ensuring staff do not carry infectious pathogens on their hands or via equipment during resident care. Isolation of Clostridium difficile from the environment and contacts of residents with antibiotic-associated colitis. Alternatively, the facility may also consider using single-use disposable devices or designating reusable equipment for only an individual resident. Equipment or items in the resident environment likely to have been contaminated with infectious fluids or other potentially infectious matter must be handled in a manner so as to prevent transmission of infectious agents. These items or equipment must be sterile when used, based on one of several accepted sterilization procedures. Most of the items in this category should be purchased as sterile or be sterilized;. High-level disinfection is traditionally defined as complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores. Single-use disposable equipment is an alternative to sterilizing reusable medical instruments. Single-use devices must be discarded after use and are never used for more than one resident. For example, a resident with influenza and signs of infection should wear a facemask. The diagnosis of many infections is based on clinical signs and symptoms, but often requires laboratory confirmation. However, since laboratory tests (especially those that depend on culture techniques) may require two or more days to complete, transmission-based precautions may need to be implemented while test results are pending, based on the clinical presentation and the 40, 51 likely category of pathogens. Furthermore, transmission-based precautions should be the least restrictive possible for the resident based on his/her clinical situation and used for the least amount of time. When used appropriately, transmission-based precautions is not to be considered involuntary seclusion. Facility staff should take measures to reduce or minimize any potential psychosocial negative effects of isolation for whom transmission-based precautions are being used. Boredom, anger, withdrawal or depression are just some of the mood changes that could occur. Implementation of Transmission-Based Precautions When implementing transmission-based precautions, consideration should be given to the 40 following: Droplet Precautions the use of droplet precautions applies when respiratory droplets contain viruses or bacteria particles which may be spread to another susceptible individual. Respiratory viruses can 59 enter thebody via the nasal mucosa, conjunctivae and less frequently the mouth. Examples of droplet-borne organisms that may cause infections include, but are not limited to Mycoplasma pneumoniae, influenza, and other respiratory viruses. Respiratory droplets are generated when an infected person coughs, sneezes, talks, or during procedures such as suctioning, endotracheal intubation, cough induction by chest 40 physiotherapy, and cardiopulmonary resuscitation. The maximum distance for droplet transmission is currently unresolved, but the area of defined risk based on epidemiological 40 findings is approximately 3-10 feet. In contrast to airborne pathogens, droplet-borne pathogens are generally not transmitted through the air over long distances. If substantial spraying of respiratory secretions is anticipated, gloves and gown as well as goggles (or face shield in place of goggles) 40 should be worn. The preference for a resident on droplet precautions would be to place the 40 resident in a private room. Spatial separation of at least 3 feet and drawing the curtain between resident beds is especially important for residents in multi-bed rooms with infections transmitted by the droplet 40 route. Airborne Precautions Airborne transmission occurs when pathogens are so small that they can be easily dispersed in the air, and because of this, there is a risk of transmitting the disease through inhalation. These small particles containing infectious agents may be dispersed over long distances by air currents and may be inhaled by individuals who have not had face-to-face contact with (or been in the same room with) the infectious individual. Staff caring for residents on airborne precautions 40 should wear a fit-tested N95 or higher level respirator that is donned prior to room entry. Point-of-Care Testing Point-of-care testing is diagnostic testing that is performed at or near the site of resident care. This may be accomplished through use of portable, handheld instruments such as blood glucose meters or prothrombin time meters. This testing may involve obtaining a blood specimen from the resident using a fingerstick device. The guidance regarding fingerstick devices and blood glucose meters is applicable to other point-of-care devices where a blood specimen is obtained. This practice prevents inadvertent reuse of fingerstick devices for more than one person. Additionally, the use of single-use, auto-disabling fingerstick devices protects healthcare staff from needlestick injuries. If reusable fingerstick devices are used for assisted monitoring of blood glucose, then they must never be used for more than one resident. Outbreak episodes have been largely due to transmission of Hepatitis B and C viruses. Please note that 70% ethanol solutions are not effective against viral bloodborne pathogens and the use of 10% bleach solutions may lead to physical degradation of your device. If manufacturers are unable to provide this information then the meter should not be 60 used for multiple patients? Blood glucose meters dedicated for single-resident use should be stored in a manner that will protect against inadvertent use of the device for additional residents and also cross contamination via contact with other meters or equipment. If multi-dose vials enter the immediate resident treatment area, they should be discarded immediately after use. These devices are designed to permit self-injection and are intended for single-person use, using a new needle for each injection. Insulin pens are designed to be used multiple times by a single resident only and must never be shared. Regurgitation of blood into the insulin cartridge after injection will create a risk of blood borne pathogen transmission if the pen is used for more than one resident, even when the needle is changed. If noncompliance is found, surveyors must cite at this tag and utilize the guidelines in Appendix Q for immediate jeopardy. Intravascular access devices such as implanted ports may be accessedmultiple times per day, for hemodynamic measurements or to obtain samples for laboratory analysis, thus increasing the risk of contamination and subsequent clinical infection. The facility must monitor to ensure that the laundry practices are implemented, any deviations from practices must be identified, and corrective actions are put in place. Laundry services may be provided onsite or the facility may have a written agreement in place for offsite laundry services. Regardless of the location where the laundry is processed, the facility must ensure that all laundry is handled, stored, processed and transported in a safe and sanitary method. Handling Laundry the facility staff should handle all used laundry as potentially contaminated and use standard precautions. Alternatively, if not all used linens are handled as potentially contaminated, staff would provide separation with special identification of bags and containers for contaminated linens with labels, color coding, or other alternative means of separation of the laundry for appropriate handling and processing. Transport of Laundry the facility practices must include how staff will handle and transport the laundry with appropriate measures to prevent cross-contamination. If this is not possible, the contaminated linen cart should be thoroughly cleaned and disinfected per 58 facility protocol before being used to move clean linens; and. Linen Storage Facility practices must address linen storage, and should include but are not limited to: The use of separate rooms, closets, or other designated spaces with a closing door provides the most secure 61 methods for reducing the risk of accidental contamination. Processing Laundry Including the Use of Laundry Equipment and Detergents in the Facility the facility must have a process to clean laundry. Detergent and water physically remove many microorganisms from the linen through dilution during the wash cycle. Advances in laundry equipment technology allow modern-day detergents to be much more effective in removing soil and reducing the presence of microbes than those used in the past when much of the research on laundry processing was first conducted. A chlorine bleach rinse is not required for all laundry items processed in low temperaturewashing environments due to the availability of modern laundry detergents that are able toproduce hygienically clean laundry without the presence of chlorine bleach. Offsite Professional Laundry Services If linen is sent off-site to a professional laundry, the facility has practices that address how the service will be provided, including how linen is processed and handled to prevent contamination from dust and dirt during loading and transport. The facility should assure that this laundry service meets healthcare industry laundry standards. Mattresses and Pillows Standard permeable mattresses and pillows can become contaminated with body substances duringresident care if the integrity of the covers of these items is compromised. A mattress cover is generally a fitted, protective material, the purpose of which is to prevent the mattress from becoming contaminated with body fluids and substances. Patches for tears and holes in mattress covers do not provide an impermeable surface over the mattress. The surveyor should corroborate any concerns observed through interviews and record and/or document review. Observations Specific observations for the provision of infection prevention and control practices such as following standard precautions. Observe care of a resident on transmission based precautions, if any, to determine if implemented appropriately based on precaution type. If concerns are identified, expand the sample to include more residents with transmission-based precautions. In addition, any potential concerns should be followed up with interviews and record reviews as needed. These must include: o When and to whom possible incidents of communicable diseases should be reported; o Developing and implementing a system of surveillance to identify infections or communicable diseases; o How to use standard precautions (to include appropriate hand hygiene) and how and when to use transmission-based precautions. This practice of reusing fingerstick devices for more than one resident created an immediate jeopardy to resident health by potentially exposing residents who required blood glucose testing to the spread of blood borne infections in the facility. As a result, several residents in an adjoining unit became seriously ill with diarrheal illnesses resulting in dehydration. A resident was observed to have an acute onset of vomiting and diarrhea resulting in soiled clothing and linens. The nursing staff removed the soiled/contaminated clothing and linens, rinsed them out in the bathroom sink, and placed the wet/soiled linen onto the floor. The bathroom was shared with a roommate who utilized the sink for oral hygiene purposes and stored his/her toothbrush and glass on the sink. The roommate, subsequently developed vomiting and diarrhea, with the development of severe dehydration, resulting in hospitalization. An Example of Severity Level 3 Non-Compliance: Actual Harm that is not Immediate Jeopardy includes but is not limited to: A month later, multiple residents developed a red, pin-point rash with severe itching, which was not present prior to resident A being admitted. The facility failed to identify through assessment and therefore, implement control measures to prevent the transmission of scabies among multiple residents in the facility, causing the residents physical harm. In addition to the physical harm, the residents experienced psychosocial harm due to anxiety and loss of sleep from severe itching and lack of timely diagnosis. The nurse administered medications to a resident via a gastric tube and while wearing the samegloves proceeded to administer oral medications to another resident. The nurse did not remove the used gloves nor perform hand hygiene between the two residents. As a result, the potential exists for transmission of organisms from contaminated uniforms to residents during the delivery of care. A nursing assistant was observed removing bed linens contaminated with urine and fecal material without the use of gloves, and carrying the contaminated linens against his/her uniform down the hall to the laundry bin. As a result, the potential existed for transmission of organisms between residents who received dressing changes. There were no infection control findings outside of annual review and documentation. Data from injectable, scheduled drug tracking should be regularly reviewed and discrepancies or unusual access patterns are investigated including whether residents should be screened for exposure to blood borne pathogens (refer to ?483. This can be accomplished through improving antibiotic prescribing, administration, and management 62 Centers for Disease Control and Prevention. Oxacillin-resistant Staphylococcus aureus): Staphylococcus aureus bacteria that are resistant to treatment with one of the semi-synthetic penicillins. This means that the antibiotic is prescribed for the correct indication, dose, and duration to appropriately treat the resident while also attempting to reduce the development of antibiotic-resistant organisms. Nursing home residents are at risk for adverse outcomes associated with the inappropriate use of antibiotics that may include but are not limited to the following: The facility must develop an antibiotic stewardship program which includes the development of protocols and a system to monitor antibiotic use. This development should include leadership support and accountability via the participation of the medical director, consulting pharmacist, nursing and administrative leadership, and individual with designated responsibility for the 63 infection control program if different. The antibiotic stewardship program protocols shall describe how the program will be implemented and antibiotic use will be monitored, consequently protocols must: Examples may include the following: o Summarizing antibiotic use from pharmacy data, such as the rate of new starts, types 63 of antibiotics prescribed, or days of antibiotic treatment per 1,000 resident days; o Summarizing antibiotic resistance. Feedback on prescribing practices and compliance with facility antibiotic use protocols may include information from medical record reviews for new antibiotic starts to determine whether the resident had signs or symptoms of an infection; laboratory tests ordered and the results; prescription documentation including the indication for use. The Antibiotic Stewardship Program in Relation to Pharmacy Services the assessment, monitoring, and communication of antibiotic use shall occur by a licensed pharmacist in accordance with ?483. Effect of a multifaceted intervention on number of antimicrobial prescriptions for suspected urinary tract infections in residents of nursing homes: Cluster randomised controlled trial. Specific Concerns That May Warrant Further Investigation If concerns have been identified, it may be necessary to conduct record reviews of one (or more) residents receiving antibiotics to identify whether the documented indication for the use of the antibiotic, dosage, and duration is appropriate. Medical record review indicated the prescribing practitioner had ordered a culture and sensitivity for a resident and prescribed an antibiotic for treatment of pneumonia prior to receipt of the results of the lab test. The facility received the results of the lab test which indicated that the bacteria was resistant to the antibiotic prescribed, however, they did not provide this information to the practitioner. As a result, the antibiotic was not adjusted accordingly and the resident was hospitalized for complications related to the pneumonia. Based on record review, two residents were currently being treated with antibiotics without an appropriate indication for use. There was no established criteria for use in the facility for when to treat a catheter associated urinary tract infection. As a result of the antibiotic therapy, the two residents developed numerous watery, foul-smelling stools, elevated temperature, nausea, and decreased appetite. The medical record revealed that stool cultures identified positive bacteria for antibiotic-related colitis (C. The two residents were treated for antibiotic-related colitis, but did not require hospitalization and fully recovered. An Example of Severity Level 2 Non-Compliance: No Actual Harm with Potential for more than Minimal Harm that is not Immediate Jeopardy includes but is not limited to: However, the risk for this happening is less than expected with medical contraindications. Establishing an immunization program against influenza and pneumococcal disease facilitates achievement of this objective. Pneumococcal pneumonia, a type of bacterial pneumonia, is a common cause of hospitalization and death in older people. People 65 years or older are two to three times more likely than the younger population to get pneumococcal infections.
Alternative first-line regimens also include carboplatin or taxane-based Chemotherapy for Metastatic Disease regimens (category 2B) or single-agent chemotherapy (category 2B) arterial bleeding order sotalol on line amex. The specific chemotherapy regimen recommended partially depends on the presence or absence of medical comorbidities blood pressure jump buy 40mg sotalol with mastercard, such as cardiac the performance status of the patient is a major determinant in the disease and renal dysfunction heart attack ukulele discount 40mg sotalol fast delivery, along with the risk classification of the selection of a regimen blood pressure chart and pulse 40mg sotalol sale. In general blood pressure xls purchase generic sotalol, long-term survival with recommended in patients with compromised liver or renal status or combination chemotherapy alone has been reported only in good-risk serious comorbid conditions blood pressure cheap sotalol american express. Poor-risk patients blood pressure for children discount 40mg sotalol with visa, defined as those with poor are appropriate first-line options (see Targeted Therapies in the performance status or visceral disease blood pressure chart during exercise buy sotalol overnight delivery, have consistently shown very discussion). Alternatively, carboplatin may be substituted for cisplatin in poor tolerance to multiagent combination programs and few complete the metastatic setting for cisplatin-ineligible patients such as those with remissions, which are prerequisites for cure. Chemotherapy may be continued for a statistically significant in the intent-to-treat analysis. The incidence of neutropenic fever status, extent of disease, and specific prior therapy. Panelists feel that the risk of adding paclitaxel outweighs the after adjuvant chemotherapy. The alternative regimens, 178 179 Studies have shown that surgery or radiotherapy may be feasible in including cisplatin/paclitaxel, gemcitabine/paclitaxel, 180 181 highly select cases for patients who show a major partial response in a cisplatin/gemcitabine/paclitaxel, carboplatin/gemcitabine/paclitaxel, 182 previously unresectable primary tumor or who have a solitary site of and cisplatin/gemcitabine/docetaxel, have shown modest activity in residual disease that is resectable after chemotherapy. Category 1 level series, this approach has been shown to afford a survival benefit. If evidence now supports the use of checkpoint inhibitors in patients with disease is completely resected, 2 additional cycles of chemotherapy advanced disease previously treated with a platinum-containing can be considered, depending on patient tolerance. The tolerate cisplatin because of renal impairment or other comorbidities available options depend on what was given as first line. Additionally, atezolizumab and pembrolizumab are approved as patients treated with pembrolizumab at the time of data cutoff. These data are comparable to the who are ineligible for cisplatin-based chemotherapy. The first results from this trial reported on 96 patients standard platinum-based regimen showed that 46. Median duration of response was not yet reached at time of patients who had previously received a checkpoint inhibitor (n = 21). With the exception of pembrolizumab as a subsequent retrospective analysis has shown that neoadjuvant chemotherapy may treatment option (category 1), the use of targeted therapies are all have a modest benefit for other variant histologies. Non-Urothelial Carcinomas of the Bladder Some of the general principles of management applicable to urothelial Approximately 10% of bladder tumors are non-urothelial carcinomas are appropriate with minor variations. In Upper tract tumors, including those that originate in the renal pelvis or in general, patients with non-urothelial invasive disease are treated with the ureter, are relatively uncommon. For example, adenocarcinomas are managed surgically with radical or partial cystectomy and with individualized adjuvant Tumors that develop in the renal pelvis may be identified during chemotherapy and radiotherapy for maximum benefit. These tumors may also be However, overall experience with chemotherapy in non-urothelial detected during an assessment to pinpoint the source of a positive carcinomas is limited. Urine cytology obtained from a urine sample or during a cystoscopy Alternatively, a nephron-sparing procedure through a transureteroscopic may help identify carcinoma cells. Hematologic, renal, and hepatic approach or a percutaneous approach may be used, with or without function should also be evaluated. High-grade tumors or renal scan or bone scan, may be needed if indicated by the test results those that are large and/or invade the renal parenchyma are managed or by the presence of specific symptoms. In the settings of positive upper tract cytology but negative imaging and biopsy studies, treatment remains controversial and appropriate Well-differentiated tumors of low grade may be managed with a management is currently poorly defined. Frequent monitoring for nephroureterectomy with a bladder cuff with or without perioperative disease is necessary for these patients. Favorable clinical and pathologic criteria for chemotherapy by up to a week to administer a cystogram confirming nephron preservation include a papillary, unifocal, low-grade tumor, and size <1. Follow-up should be the same as pT0/pT1 disease with the trials, systematic reviews of retrospective studies have shown that addition of chest imaging. In addition, patients with bilateral disease, solitary functional or anatomic kidney, chronic kidney Ureteral tumors may develop de novo or in patients who have disease, renal insufficiency, or a hereditary predisposition to undergone successful treatment for superficial tumors that originate in genitourinary cancers are contraindicated from nephroureterectomy and the bladder. More extensive lesions may result in pain or treatment due to a high risk of disease recurrence. Follow-up Workup Subsequent management is dictated by the extent of disease at the evaluation is similar to that outlined for tumors that originate in the surgery. The specific procedure required varies depending on the or nodal disease has been mixed. A retrospective study of 1544 location of the tumor (upper, mid, or distal location) and disease extent. A portion of the bladder is removed to Tumors, above, for more discussion of the data on adjuvant therapy for ensure complete removal of the entire intramural ureter. Tumors that originate in the mid portion can be divided by grade and Urothelial Carcinomas of the Prostate size. Small, low-grade tumors can be managed with excision followed Urothelial (transitional cell) carcinomas of the prostate represent a by ureteroureterostomy, segmental or complete ureterectomy, or ileal distinct entity with a unique staging system. Alternatively, endoscopic be distinguished from urothelial carcinomas of bladder origin that invade resection or nephroureterectomy with a bladder cuff can be performed. Urothelial carcinomas of the Larger, high-grade lesions are managed with nephroureterectomy with prostate may occur de novo or, more typically, concurrently or after a bladder cuff and regional lymphadenectomy. Similar to tumors originating in other sites chemotherapy can be considered in select patients. Prostate-specific patients with distal ureteral tumors following distal ureterectomy or the antigen testing should be performed. The final pathologic stage is used to guide subsequent management, as is the case for tumors that originate in other sites. No adjuvant therapy Primary Treatment is advised for lesions that are pT1 or less, but serial follow-up of the Pending histologic confirmation, tumors that are limited to the mucosal urothelial tracts or remaining unit (as previously described under Renal prostatic urethra with no acinar or stromal invasion can be managed Pelvis Tumors) is recommended. If local recurrence is seen, Patients with more extensive disease are advised to consider systemic cystoprostatectomy with or without urethrectomy is recommended. Based on data extrapolated from bladder cancer therapy, Patients with Tis, Ta, or T1 disease should have a repeat transurethral neoadjuvant chemotherapy may be considered in patients with stromal or transvaginal resection. For male patients with pendulous urethra, a distal cystoprostatectomy with or without urethrectomy. Patients may Primary Carcinoma of the Urethra consider neoadjuvant chemotherapy (category 2B) or chemoradiation (category 2A) before a urethrectomy. Unlike for bladder margins may undergo additional surgery or radiation, preferably with cancer, squamous cell carcinoma is the most common histologic 232 233,234 chemotherapy. At recurrence, options include systemic therapy, total subtype for urethral cancer. Recurrent cases may be treated with systemic histologies (ie, squamous, transitional, adenocarcinomas) with the therapy and/or radiation. Initial treatment options for female patients with T2 tumors include chemoradiation or urethrectomy with cystectomy. Partial urethrectomy Workup 235 has been associated with a high urethral recurrence rate. At A cystourethroscopy should be performed if carcinoma of the urethra is recurrence, the patient may receive systemic therapy or suspected. A multimodal treatment approach (ie, surgery, systemic therapy, If palpable inguinal lymph nodes are present, a chest/abdominal/pelvic radiation) is common for advanced disease. If systemic therapy is used, the involve combined modality approaches using recently developed choice of regimen should be based on histology. Although these are not appropriate in all cases, neoadjuvant chemotherapy followed by consolidative surgery or they offer the promise of an improved quality of life and prolonged radiation, or radiation preferably with chemotherapy with or without survival. If positive nodes are present, radiation preferably Finally, within the category of metastatic disease, several new agents with chemotherapy is the preferred treatment for squamous cell have been identified that seem superior to those currently considered carcinoma. Checkpoint inhibitors, in particular, have emerged consolidative surgery are also treatment options. Experts patient may undergo pelvic exenteration (category 2B) with or without surmise that the treatment of urothelial tumors will evolve rapidly over ilioinguinal lymphadenectomy and/or chemoradiotherapy. Patients with distant metastases should receive similar treatment as metastatic bladder cancer. Systemic therapies include chemotherapy and checkpoint inhibitors as subsequent-line options. However, it should be noted that checkpoint inhibitors have only been evaluated in patients with urothelial histology. Summary Urothelial tumors represent a spectrum of diseases with a range of prognoses. After a tumor is diagnosed anywhere within the urothelial tract, the patient remains at risk for developing a new lesion at the same or a different location and with a similar or more advanced stage. Bladder Cancer: Diagnosis and an update on etiology, molecular development, classification, and Treatment. Medicine recurrence and progression in individual patients with stage Ta T1 (Baltimore) 2017;96:e8588. Improved detection of bladder cancer risk and oncologic outcomes in type 2 diabetes mellitus urothelial carcinoma in situ with hexaminolevulinate fluorescence patients: A systematic review and meta-analysis. A comparison of hexaminolevulinate fluorescence cystoscopy and white light cystoscopy 24. Applying narrow-band imaging in fluorescence cystoscopy reduces recurrence in patients with nonmuscle complement with white-light imaging cystoscopy in the detection of invasive bladder cancer. Narrow-band imaging transurethral resection of bladder tumours reduces bladder tumour cystoscopy in non-muscle-invasive bladder cancer: a prospective recurrence due to less residual tumour tissue in Ta/T1 patients: a comparison to the standard approach. Therapeutic outcome of fluorescence cystoscopy in the detection of primary non-muscle invasive bladder cystoscopy guided transurethral resection in patients with non-muscle cancer: a "second look" matters? Evaluation of narrow band imaging as a complementary method for the detection of bladder 21. Available at: of non-muscle-invasive bladder cancer with hexaminolevulinate. Available at: fluorescence cystoscopy in the diagnosis and follow-up of patients with. Available at: primary non-muscle-invasive bladder cancer patients: Trial protocol and. Narrow band imaging-assisted transurethral resection with transurethral resection alone in patients with transurethral resection reduces the recurrence risk of non-muscle stage pTa-pT1 urothelial carcinoma of the bladder: Which patients invasive bladder cancer: A systematic review and meta-analysis. A comparison of white-light cystoscopy and instillation of gemcitabine vs saline immediately following resection of narrow-band imaging cystoscopy to detect bladder tumour recurrences. Available at: classification of tumours of the urinary system and male genital organs. Available at: Recent developments and highlights of the new 2016 World Health. Organization classification of tumors of the urinary system and male genital organs. Histologic variants of urothelial published results of randomized clinical trials. J Urol 2005;174:86-91; bladder cancer and nonurothelial histology in bladder cancer. The impact of intravesical gemcitabine and 1/3 dose Bacillus Calmette-Guerin instillation therapy 45. A meta-analysis 30911 comparing intravesical instillations of epirubicin, bacillus of randomized trials. Available at: Calmette-Guerin, and bacillus Calmette-Guerin plus isoniazid in patients. Available at: is superior to a combination of epirubicin and interferon-alpha2b in the. Guerin is superior to mitomycin C in reducing tumour recurrence in high-risk superficial bladder cancer: a meta-analysis of randomized 54. Eur Urol 2009;56:247 Guerin treatment of non-muscle-invasive bladder cancer: a critical 256. Long-term efficacy of maintenance bacillus Calmette-Guerin versus maintenance mitomycin 56. Intravesical bacillus Calmette and success in stage Ta grade 3 bladder tumors treated with low dose Guerin reduces the risk of progression in patients with superficial bacillus Calmette-Guerin instillations. Available bladder cancer: a meta-analysis of the published results of randomized at: Organisation for Research and Treatment of Cancer Genito-Urinary Jpn J Clin Oncol 2005;35:395-399. The effect of ofloxacin on the Market: Rationalizing the Shortage of Bacillus Calmette-Guerin. Eur bacillus calmette-guerin induced toxicity in patients with superficial Urol Focus 2018;4:481-484. Available at: bladder cancer: results of a randomized, prospective, double-blind. Oncological outcomes of bacille Calmette-Guerin after initial bacille Calmette-Guerin failure in sequential intravesical gemcitabine and docetaxel in patients with non non-muscle-invasive bladder cancer: a multicenter prospective muscle invasive bladder cancer. Long-term intravesical gemcitabine and mitomycin C chemotherapy regimen in intravesical adjuvant chemotherapy further reduces recurrence rate patients with non-muscle invasive bladder cancer. Urol Oncol compared with short-term intravesical chemotherapy and short-term 2010;28:510-514. Treatment strategy for newly diagnosed T1 high-grade bladder urothelial carcinoma: New 71. Treatment of Nonmuscle Invasive Bladder Cancer: A Systematic Available at: Efficacy and tolerance of one third full dose bacillus Calmette-Guerin maintenance therapy every 3 72. Available at: Guerin plus isoniazid for intermediate and high risk Ta, T1 papillary. Available at: study of the efficacy, safety and quality of life with low dose bacillus. Available at: chemotherapy on recurrence rate of recurrent superficial transitional cell. Available at: chemotherapy prophylaxis in primary superficial bladder cancer: a. Available at: bladder cancer and recurrence after 2 prior courses of intravesical. The value of a second transurethral resection in evaluating patients with bladder tumors. Restaging transurethral resection of bladder tumor for high-risk stage Ta and T1 bladder cancer. The effect of repeat transurethral resection on recurrence and progression rates in patients 93. Eur Urol 2006;49:303-306; discussion prediction of muscle-invasiveness of bladder cancer: A systematic 306-307. Discrepancy based combination chemotherapy in patients with invasive bladder between clinical and pathologic stage: impact on prognosis after radical cancer: a combined analysis of two Nordic studies. Neoadjuvant Lymphadenectomy in patients with transitional cell carcinoma of the chemotherapy for transitional cell carcinoma of the bladder: a urinary bladder; significance for staging and prognosis. Impact of the number of recent clinical trials for perioperative systemic therapy for muscle lymph nodes retrieved on outcome in patients with muscle invasive invasive bladder cancer: a systematic review. J Clin chemotherapy in invasive bladder cancer: update of a systematic review Oncol 2004;22:2781-2789. Available at: and meta-analysis of individual patient data advanced bladder cancer. J Clin Oncol methotrexate, vinblastine, doxorubicin, and cisplatin is safe, effective, 2009;27:5680-5684. Available at: and efficient neoadjuvant treatment for muscle-invasive bladder cancer: Available at: dense methotrexate, vinblastine, doxorubicin, and cisplatin with. Available at: expression signature in the molecular classification of chemotherapy. The role of adjuvant methotrexate, vinblastine, doxorubicin, and cisplatin with bevacizumab chemotherapy following cystectomy for invasive bladder cancer: a in urothelial cancer. Adjuvant sandwich advanced urothelial tract tumors: European Organization for Research chemotherapy plus radiotherapy vs adjuvant chemotherapy alone for and Treatment of Cancer Protocol no. J Clin Oncol locally advanced bladder cancer after radical cystectomy: A randomized 2001;19:2638-2646. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in 133. Risk prediction models of bladder cancer: evidence from the National Cancer Database, 2003 to locoregional failure after radical cystectomy for urothelial carcinoma: 2007. Use of potentially curative therapies for muscle-invasive bladder cancer in the United States: 129. Trimodalities for bladder cancer in elderly: Transurethral resection, hypofractionated 130. Semin results of two prospective bladder-sparing trimodality approaches for Oncol 1990;17:606-612. Available at: invasive bladder cancer: neoadjuvant chemotherapy and concurrent. Combined radiation and chemotherapy for invasive transitional-cell carcinoma of the bladder: a 147. Oncologist 2000;5:471 preservation by combined modality protocol treatment: long-term 476. Int J Radiat Oncol Biol Phys neoadjuvant chemotherapy in patients with invasive bladder cancer 2003;57:665-672. Available at: treated with selective bladder preservation by combined radiation.
Transient radicular irritation after spinal anaesthesia with hyperbaric 5% lignocaine blood pressure medication yellow teeth purchase 40mg sotalol overnight delivery. Bilateral severe pain at L3-4 after spinal anaesthesia with hyperbaric 5% lignocaine blood pressure medication new zealand cheap sotalol 40mg otc. Prospective study of the incidence of transient radicular irritation in patients undergoing spinal anesthesia pulse pressure low diastolic buy 40 mg sotalol visa. Transient neurologic symptoms after spinal anes thesia with lidocaine versus other local anesthetics: a systematic review of randomized blood pressure medication list order sotalol 40mg amex, controlled trials hypertension of the knee generic 40 mg sotalol with amex. Irreversible conduction block in isolated nerve by high concentrations of local anesthetics blood pressure jumps from low to high order sotalol from india. Concentration dependence of lidocaine-induced irreversible conduction loss in frog nerve arrhythmia when i lay down purchase sotalol 40mg online. Cauda equina syndrome following a single spinal administration of 5% hyperbaric lidocaine through a 25-gauge Whitacre needle arteria en ingles buy generic sotalol pills. Epinephrine increases the neurologic poten tial of intrathecally administered local anesthetic in the rat [abstract]. Local anesthetic neurotoxicity does not result from blockade of voltage-gated sodium channels. An in vitro study of dural lesions pro duced by 25-gauge Quincke and Whitacre needles evaluated by scanning electron micros copy. Epidural blood patch: evaluation of the volume and spread of blood injected into epidural space. Radiological examination of the intrathecal position of the microcathe ters in continuous spinal anaesthesia. Post-dural puncture headache in young adults: comparison of two small-gauge spinal catheters with different needle design. Comparison of three catheter sets for continuous spinal anesthesia in patients undergoing total hip or knee arthroplasty. Comparison 1 Any washout versus no washout, Outcome 4 Mean number of episodes of high temperature. Comparison 1 Any washout versus no washout, Outcome 5 Mean number of episodes of high temperature of poss urinary origin. Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 3, 2017. A B S T R A C T Background People requiring long-term bladder draining with an indwelling catheter can experience catheter blockage. Regimens involving different solutions can be used to wash out catheters with the aim of preventing blockage. Objectives To determine if certain washout regimens are better than others in terms of effectiveness, acceptability, complications, quality of life and critically appraise and summarise economic evidence for the management of long-term indwelling urinary catheterisation in adults. Selection criteria All randomised and quasi-randomised trials comparing catheter washout policies. Washout policies in long-term indwelling urinary catheterisation in adults (Review) 1 Copyright 2017 the Cochrane Collaboration. Main results We included seven trials involving a total of 349 participants, 217 of whom completed the studies. Analyses of three cross-over trials yielded suboptimal results because they were based on between-group differences rather than individual participants? differences for sequential interventions. Two parallel group trials had limited clinical value: one combined results for suprapubic and urethral catheters and the other provided data for only four participants. The included studies reported data on six of the nine primary and secondary outcome measures. None of the trials addressed: number of catheters used, washout acceptability measures (including patient satisfaction, patient discomfort, pain and ease of use), or health status/measures of psychological health; very limited data were collected for health economic outcomes. We are uncertain if washout solutions (saline or acidic), compared to no washout solutions, has an important effect on the rate of symptomatic urinary tract infection or length of time each catheter was in situ because the results are imprecise. Four trials compared different types of washout solution; saline versus acidic solutions (2 trials); saline versus acidic solution versus antibiotic solution (1 trial); saline versus antimicrobial solution (1 trial). We are uncertain if type of washout solution has an important effect on the rate of symptomatic urinary tract infection or length of time each catheter was in situ because the results are imprecise. Weareuncertainifdifferentcompositions of acidic solutions has an important effect on the rate of symptomatic urinary tract infection or length of time each catheter was in situ because only 14 participants (of 25 who were recruited) completed this 12 week, three arm trial. The high risk of bias of the included studies resulted in the evidence being graded as low or very low quality. Authors? conclusions Data from seven trials that compared different washout policies were limited, and generally, of poor methodological quality or were poorly reported. Trials comparing different washout solutions, washout volumes, and frequencies or timings are also needed. P L A I N L A N G U A G E S U M M A R Y How effective are urinary catheter washout solutions? Review question We aimed to assess effectiveness of urinary catheter washout solutions. Background For a range of reasons, some people are unable to empty their bladders properly or leak urine (urinary incontinence). Urinary catheters, which are soft tubes inserted into the bladder to drain urine to a collection bag, are often used to help people with urinary incontinence. Washout policies in long-term indwelling urinary catheterisation in adults (Review) 2 Copyright 2017 the Cochrane Collaboration. Blockages may affect half of all people with long-term catheters causing pain and distress. Liquid solutions may be injected into the catheter to prevent or relieve blockages. These problems mean that assistance from healthcare professionals is needed for people with urinary catheter blockages. Study characteristics We included seven studies that presented information on 217 people who completed the studies of 349 who started in the trials. People were allocated randomly to have catheter washouts or not, and the effects compared. Four studies reported on possible harmful effects of washout use, such as blood in the washout solution, changes in blood pressure and bladder spasms. Study funding sources the included studies were funded by Novobay Pharmaceuticals Inc (Linsenmeyer 2014); Alberta Heritage Foundation for Medical Research and the Canadian Nurses Foundation (Moore 2009); National institute of Aging, National Institutes of Health (Muncie 1989); Paralyzed Veterans of America Spinal Cord Research Foundation (Waites 2006). Key results There was not enough good research evidence to determine if catheter washouts were useful. Quality of the evidence the included trials were generally small with methodological? This included limited details on how participants were randomly allocated into groups and how both participants and researchers were blinded to these groups. Washout policies in long-term indwelling urinary catheterisation in adults (Review) 3 Copyright 2017 the Cochrane Collaboration. S R R T R A m -t m P m lli n lt s S l a m I n C m O m m k * (95 % I) m m (95 % I) (s) (G) A m k k N S m m 0 1 0 0 0 1 0 53 m (N m (0 0) t i m le (1 1 m i p m m U T t o m U T o li n s S m m m m t i m le 3 M m (1 45 n m o m (s li n (s li n n : 0. Concerns exist that use of washouts can damage the bladder mu cosa and increase infection rates due to opening the closed catheter Description of the condition system. Use of antiseptic washouts is also believed to be of little incontinence or chronic bladder outlet obstruction. People with is the formation of encrustations on the luminal and outer sur conditions such as multiple sclerosis, dementia, stroke, spina bi faces of the catheter with consequent blockage and by-passing of? Nearly half of all people with an Numbers of people being managed using long-term catheters is indwelling catheter experience problems with catheter blockage dif? Between April and May 2013, 1181 long due to encrustation (Getliffe1992; Kohler-Ockmore 1996; Kunin term care facilitiesinEurope participated inapoint prevalence sur 1987; Roe 1987). Blockage of an indwelling catheter is traumatic, vey of healthcare-associated infection and related risk factors. The most commonly isolated bacteria median percentage of long-term care facility residents with a uri in blockages is Proteus mirabilis (Stickler 2010), which may cause nary catheter was6. The percentage of people receiving care at home with a caused by the metabolism of urea to ammonia and bicarbonate urinary catheter was estimated to be 5. Those using catheters long-term often experience complications such as blockage, leak age and infection. Candiduria is generally asymptomatic but rare is the root cause of catheter-associated complications. Bacteriuria complications can include fungal balls in the bladder or renal risk increases with days of catheterisation (Garibaldi 1974; Stark pelvis, kidney infection and disseminated candidiasis (infection 1984); over time, all people with a catheter will develop bacteruria with Candida spp). Increased levels of bacteriuria may expose people to catheter-associated candiduria is unclear. Up to 30% persists or must remain catheterised, several management tech of long-term catheterised people will become symptomatic and niques have been used, primarily involving oral medication or require some intervention (Saint 1999). People with urinary istration (continuous irrigation), in the treatment of fungal infec catheters are up to 6. Over the last fewdecades, variousantibi crustation and blockage varies but is largely dependent on the use otic and antiseptic solutions have been used as washout solutions of catheter maintenance solutions. Treatments commonly used for Washout policies in long-term indwelling urinary catheterisation in adults (Review) 7 Copyright 2017 the Cochrane Collaboration. Adults whose treatment combined intermittent catheterisation with pe How the intervention might work riods of indwelling catheterisation were included only if the in Invitroevidencesuggeststhatnormalsalineisineffectiveindimin dwelling catheter had been in situ for more than 28 days at the ishing encrustations but there is some evidence that methenamine time of data collection. Furthermore, none of the continence advisers questioned in a 1993 study thought that reg the interventionsconsidered included catheter washoutswith wa ular washouts were useful compared to 25% of district nurses who ter, saline, antiseptic, acidic, antimicrobial or antibiotic solutions thought they were (Capewell 1993). Studies were considered that com rounding the effectiveness of washouts for managing encrustation pared: and blockage, they are widely used (Pomfret 2004). The wide variety of solutions Throughout the literature, the terminology used to refer to available, combined with the multiplicity of possible procedures the ?washing-out? of catheters is somewhat confusing. In this review all trials referring to catheter or bladder washouts were considered with the exception of post-surgical bladder irri gations, therapeutic bladder instillations used, for example, in the treatment of people with cancer, and continuous irrigations with O B J E C T I V E S antifungal solutions. Trials that involved irrigation of catheter drainage bags were not To determine if certain washout regimens are better than others considered in this review. Other types of interventions to prevent in terms of effectiveness, acceptability, complications, quality of or reduce encrustation or infection, such as changes in? Washout policies in long-term indwelling urinary catheterisation in adults (Review) 8 Copyright 2017 the Cochrane Collaboration. Types of outcome measures regimens, and any reports of formal economic evaluations of washouts, such as cost-effectiveness or cost-utility analysis. Primary outcomes Catheter washoutswere introduced toprevent or reduce the occur Search methods for identi? In recent years their use has We did not impose any language or other limitations on the beenprimarily aimed at minimisingthe effectsof recurrent encrus searches. Searches performed by the review authors for the 2010 version of Reported levels of patient discomfort associated with washouts; this review (Hagen 2010) are detailed in Appendix 2. Measures of complications or adverse effects of washouts Data collection and analysis Adverse effects that result at the time of washout administration, such as inability to tolerate washout solution and irritation or Selection of studies trauma to urethral or bladder tissue were considered. Methods: study design, total duration of study, details of We used a data collection form for study characteristics and out any run-in period, number of study centres and location, study come data which was used for the 2010 version of this review setting, withdrawals, random allocation sequence, outcome (Hagen 2010). Participants: N, mean age, age range, gender, inclusion We planned to analyse cross-over trials with continuous outcomes criteria, and exclusion criteria. Interventions: intervention, comparison, method of ference between treatment periods; however, data from cross-over administration. Where this was not possible, and the missing data were included studies if outcome data were not reported in a usable thoughttointroduceseriousbias,weplannedtoexploretheimpact way. We double checked that data were entered correctly by comparing the data presented in the systematic review with the study reports. We assessed the risk of bias according to the following We planned that if the meta-analysis included more than 10 trials, domains. It was planned that where possible (only with two independent We graded each potential source of bias as high, low or unclear and comparisons from one trial), meta-analysis would be undertaken justi? We considered blinding separately for different yse data as recommended in section 16. Where information on risk of bias ever, no suitable data were available and meta-analysis was not related to unpublished data or correspondence with a trialist, we performed. Thiswasnotpossiblebecauseonlysingle reports); and studies were available for analyses. Washout policies in long-term indwelling urinary catheterisation in adults (Review) 11 Copyright 2017 the Cochrane Collaboration. We used methods and recommendations available (see Characteristics of ongoing studies). Participants Airaksinen 1979 studied 40 participants (16 males, 24 females) Summary of? This study comprised a within Subgroup analysis and investigation of heterogeneity patient comparison of three different solutions (saline, citric acid 3. Participants received all three washout We intended to perform subgroup analysis to explore the impact solutions but in different orders. This Sensitivity analysis study compared the use of an antimicrobial washout solution with saline. We did not conduct were living in the community with long-term catheters known to sensitivity analysis because meta-analysis was not performed. This study compared the use of citric acid washouts with planned catheter changes. Moore 2009 studied 73 (36 males, 37 females) Canadian commu nity-dwelling or long-term care adults with long-term indwelling R E S U L T S catheters that required changing every three weeks or less, requir ing supportive or continuing care. Participants were randomly as Description of studies signed to one of three groups: control (usual care, no washout), saline washout or acidic washout. The study was funded by the Alberta Heritage Foundation for Medical Research and the Cana Results of the search dian Nurses Foundation. Of these, 23 reported Muncie 1989 studied 44 long-term hospitalised female patients potentially eligible studies. This randomised cross-over trial compared saline washout not received from one author. Linsenmeyer 2014; 107 participants) to bring the total num Waites 2006 randomised 89 community-residing patients (49 ber of included studies to seven (349 participants randomised). This study was funded by the Paralyzed (Airaksinen 1979; McNicoll 2003; Moore 2009; Waites 2006) Vetrans of America Spinal Cord Research Foundation. Three trials compared washout (using saline and/or acidic solu drain into the bladder via gravity. The intervention duration was tion) with no washout (Airaksinen 1979; Moore 2009; Muncie 12 weeks (1-week normal saline washout run-in period, plus a 3 1989). Three trials compared different types of washout solution week phase with each of the solutions, and 1-week normal saline (Kennedy 1992; Linsenmeyer 2014; Waites 2006). The protocol for the planned catheter washout (containing 40 mg/mL neomycin sulphate and 200,000 removal group in McNicoll 2003 was not described, but varied U/mL polymyxin B). Moore 2009 had three arms and provided a comparison of saline and Contisol washout solutions in addition to a washout versus no washout comparison. Washout versus no washout Linsenmeyer 2014 compared different treatment regimens: 0. The control was with 50 mL sterile Contisol (also known as Suby G) (citric acid saline. Muncie 1989 compared 10 weeks of once daily normal saline washout (30 mL via syringe) with 10 weeks of no washout. New catheters were inserted at the beginning and end of each study A stronger solution of washout versus a weaker solution phase, and drainage bags were changed weekly in both groups. The intervention duration was 24 weeks (2-week no washout run In Kennedy 1992, two groups received washouts with different in period, 10-week washout or no washout phase, and 2-week no compositions of acidic solution: one solution contained 3. Airaksinen 1979 randomised 40 patients to four groups of 10 However, other chemical components of the two solutions also participants. Those groups who received the Excluded studies washout had this at two week intervals with normal saline; the volume used was 10 mL or 20 mL depending on the size of the See Characteristics of excluded studies. The volume of solution and method of administration 1987; Elliott 1989; Elliott 1990; Furuno 1998; Gelman 1980; in the washout group were not stated. The control group were to Kennedy 1984; Meyers 1964; Robertson 1990; Ruwaldt 1983; receive ?planned catheter changes? but the protocol was not de Vainrub 1977; Warren 1978). Authors weeks of twice weekly washout with Solution R (citric acid 6%, were contacted and responded that no results for this trial were gluconolactone0. All washouts were administered by attaching a is funded by NovoBay Pharmaceuticals. Further details are pre 100 mL sterile, pre-packed sachet to the catheter and allowing it to sented in Characteristics of ongoing studies. Washout policies in long-term indwelling urinary catheterisation in adults (Review) 13 Copyright 2017 the Cochrane Collaboration. Risk of bias in included studies All but one trial had at least one factor associated with risk of bias (Figure 2; Figure 3). Methodological quality graph: review authors? judgements about each methodological quality item presented as percentages across all included studies Washout policies in long-term indwelling urinary catheterisation in adults (Review) 14 Copyright 2017 the Cochrane Collaboration. Methodological quality summary: review authors? judgements about each methodological quality item for each included study Washout policies in long-term indwelling urinary catheterisation in adults (Review) 15 Copyright 2017 the Cochrane Collaboration. Allocation Selective reporting Little information was provided about the process of concealment Most trials reported all outcomes in results sections and were as of group allocation in most included trials. There was some discrepancy in outcomes re was assumed the allocation process was not concealed because ported in Airaksinen 1979 which was assessed as unclear risk of random number tables were used to determine the order in which bias. Five studies indicated that participants were this trial was judged at high risk of bias. These studies were assessed as unclear risk of Other potential sources of bias bias. Group assignment was determined by a computer-generated Only Moore 2009 stated that data were analysed using an inten list of random numbers, placed in opaque envelopes, which were tion-to-treat analysis for the primary outcome variable; that is, the opened by the participant after consent was obtained in Moore length of time each catheter was in situ was recorded as the date 2009 (low risk of bias). The remaining trials ei ther did not analyse according to the intention-to-treat principle (Linsenmeyer 2014; McNicoll 2003; Muncie 1989; Waites 2006) Blinding or this was unclear (Airaksinen 1979; Kennedy 1992).
The single-dose and steady-state pharmacokinetic parameters of empagliflozin were similar atrial fibrillation discount sotalol online amex, suggesting linear pharmacokinetics with respect to time blood pressure exercise buy sotalol online pills. The observed effect of food on empagliflozin pharmacokinetics was not considered clinically relevant and empagliflozin may be administered with or without food arrhythmia leads to heart failure order sotalol 40mg amex. Distribution the apparent steady-state volume of distribution was estimated to be 73 blood pressure fluctuation causes buy sotalol 40mg with visa. Following administration of an oral [ C]-empagliflozin solution to healthy subjects arteria glutea superior order sotalol with visa, the red blood cell partitioning was approximately 36 blood pressure medication rebound effect order sotalol in india. Metabolism No major metabolites of empagliflozin were detected in human plasma and the most abundant metabolites were three glucuronide conjugates (2-O- blood pressure chart 80 year old order sotalol 40mg without prescription, 3-O- blood pressure drops after eating buy sotalol cheap, and 6-O-glucuronide). Systemic exposure of each metabolite was less than 10% of total drug-related material. Elimination the apparent terminal elimination half-life of empagliflozin was estimated to be 12. Following administration of an oral [ C]-empagliflozin solution to healthy subjects, approximately 95. The majority of drug-related radioactivity recovered in feces was unchanged parent drug and approximately half of drug-related radioactivity excreted in urine was unchanged parent drug. Peak plasma levels of empagliflozin were roughly 20% higher in subjects with mild and severe renal impairment as compared to subjects with normal renal function. Pediatric Studies characterizing the pharmacokinetics of empagliflozin in pediatric patients have not been performed. Based on in vitro studies, empagliflozin is considered 14 unlikely to cause interactions with drugs that are P-gp substrates. Empagliflozin does not inhibit any of these human uptake transporters at clinically relevant plasma concentrations and, therefore, no effect of empagliflozin is anticipated on concomitantly administered drugs that are substrates of these uptake transporters. Empagliflozin pharmacokinetics were similar with and without coadministration of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, and simvastatin in healthy volunteers and with or without coadministration of hydrochlorothiazide and torsemide in patients with type 2 diabetes (see Figure 1). In subjects with normal renal function, coadministration of empagliflozin with probenecid resulted in a 30% decrease in the fraction of empagliflozin excreted in urine without any effect on 24-hour urinary glucose excretion. Empagliflozin did not increase the incidence of tumors in female rats dosed at 100, 300, or 700 mg/kg/day (up to 72 times the exposure from the maximum clinical dose of 25 mg). In male rats, hemangiomas of the mesenteric lymph node 16 were increased significantly at 700 mg/kg/day or approximately 42 times the exposure from a 25 mg clinical dose. Empagliflozin did not increase the incidence of tumors in female mice dosed at 100, 300, or 1000 mg/kg/day (up to 62 times the exposure from a 25 mg clinical dose). Renal tubule adenomas and carcinomas were observed in male mice at 1000 mg/kg/day, which is approximately 45 times the exposure of the maximum clinical dose of 25 mg. These tumors may be associated with a metabolic pathway predominantly present in the male mouse kidney. Mutagenesis Empagliflozin was not mutagenic or clastogenic with or without metabolic activation in the in vitro Ames +/ bacterial mutagenicity assay, the in vitro L5178Y tk mouse lymphoma cell assay, and an in vivo micronucleus assay in rats. Impairment of Fertility Empagliflozin had no effects on mating, fertility or early embryonic development in treated male or female rats up to the high dose of 700 mg/kg/day (approximately 155 times the 25 mg clinical dose in males and females, respectively). Treatment-naive patients with inadequately controlled type 2 diabetes entered an open-label placebo run-in for 2 weeks. Patients with type 2 diabetes inadequately controlled on at least 1500 mg of metformin per day entered an open label 2 week placebo run-in. Patients with inadequately controlled type 2 diabetes on at least 1500 mg per day of metformin and on a sulfonylurea, entered a 2 week open-label placebo run-in. Patients with type 2 diabetes inadequately controlled on at least 1500 mg of metformin per day entered a single blind placebo run-in period for 2 weeks. At the end of the run-in period, patients who remained inadequately controlled and had an HbA1c between 7 and 10. The differences between treatment groups for systolic blood pressure was statistically significant (p-value <0. The Week 104 analysis included data with and without concomitant glycemic rescue medication, as well as off-treatment data. Missing data for patients not providing any information at the visit were imputed based on the observed off treatment data. Patients with inadequately controlled type 2 diabetes on metformin at a dose of at least 1500 mg per day and pioglitazone at a dose of at least 30 mg per day were placed into an open-label placebo run-in for 2 weeks. Patients were maintained on a stable dose of insulin prior to enrollment, during the run-in period, and during the first 18 weeks of treatment. During an extension period with treatment for up to 52 weeks, insulin could be adjusted to achieve defined glucose target levels. Coadministered antidiabetic medications were to be kept stable for the first 12 weeks of the trial. Thereafter, antidiabetic and atherosclerotic therapies could be adjusted, at the discretion of investigators, to ensure participants were treated according to the standard care for these diseases. Approximately 72% of the study population was Caucasian, 22% was Asian, and 5% was Black. All patients in the study had inadequately controlled type 2 diabetes mellitus at baseline (HbA1c greater than or equal to 7%). At baseline, patients were treated with one (~30%) or more (~70%) antidiabetic medications including metformin (74%), insulin (48%), and sulfonylurea (43%). At baseline, approximately 81% of patients were treated with renin angiotensin system inhibitors, 65% with beta-blockers, 43% with diuretics, 77% with statins, and 86% with antiplatelet agents (mostly aspirin). The statistical analysis plan had pre-specified that the 10 and 25 mg doses would be combined. A Cox proportional hazards model was used to test for non-inferiority against the pre-specified risk margin of 1. Type-1 error was controlled across multiples tests using a hierarchical testing strategy. Results for the 10 mg and 25 mg empagliflozin doses were consistent with results for the combined dose groups. The non cardiovascular deaths were only a small proportion of deaths, and were balanced between the treatment groups (2. Instruct patients to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens. Also inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirements may change. Instruct females of reproductive potential to report pregnancies to their physicians as soon as possible. Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake. Instruct patients to check ketones (when possible) if symptoms consistent with ketoacidosis occur even if blood glucose is not elevated. Serious Urinary Tract Infections Inform patients of the potential for urinary tract infections, which may be serious. Advise them to seek medical advice if such symptoms occur [see Warnings and Precautions (5. Counsel patients to promptly seek medical attention if they develop pain or tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, along with a fever above 100. Provide them with information on the signs and symptoms of balanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis). Advise them of treatment options and when to seek medical advice [see Warnings and Precautions (5. Advise patients to report immediately any skin reaction or angioedema, and to discontinue drug until they have consulted prescribing physician [see Warnings and Precautions (5. Inform patients that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and HbA1c levels, with a goal of decreasing these levels toward the normal range. Hemoglobin A1c monitoring is especially useful for evaluating long-term glycemic control. Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk of dehydration if you: o have low blood pressure o take medicines to lower your blood pressure, including diuretics (water pills) o are on low sodium (salt) diet o have kidney problems o are 65 years of age or older. Symptoms of a vaginal yeast infection include: o vaginal odor o white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese) o vaginal itching. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include: o redness, itching, or swelling of the penis o rash of the penis o foul smelling discharge from the penis o pain in the skin around penis Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Talk to your doctor right away if you use an over-the counter antifungal medication and your symptoms do not go away. Talk with your doctor about the best way to control your blood sugar while you are pregnant. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Talk to your doctor right away if you: o reduce the amount of food or liquid you drink for example, if you are sick or cannot eat or o start to lose liquids from your body for example, from vomiting, diarrhea or being in the sun too long. Tell your doctor if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Signs and symptoms of low blood sugar may include: o headache o irritability o confusion o dizziness o drowsiness o hunger o shaking or feeling jittery o sweating o weakness o fast heartbeat. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: o pain or tenderness o swelling o redness of skin (erythema). Symptoms may include o swelling of your face, lips, throat and other areas of your skin o difficulty with swallowing or breathing. Active Ingredient: empagliflozin Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate. The other brands listed are trademarks of their respective owners and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc. Records were reviewed by two primary care physicians and a clinical microbiologist. Key words: antibiotic stewardship; asymptomatic bacteriuria; diagnosis; Malaysia; primary care; urinary tract infection. This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Studies come from western, temperate Auditing antibiotic choice is straightforward, and countries [1, 4], and it is unclear which are the studies reported that primary care doctors perform important differential diagnoses in the tropics. In Malaysia a example, as incidence of urinary calculus is high in morbidity survey in primary care showed that only Malaysia [8], this may be a more frequent differential 26/60 (43. Adherence to To assist diagnosis many studies [9-12] have prescribing advice can be improved. The clinic is attached to the teaching hospital of nitrite negative but leucocyte positive may occur in a public university in Kuala Lumpur, Malaysia. If only nitrites are positive, not leucocytes, attending this clinic were seen by non-specialist bacteria are confirmed in the urine, but they may be medical doctors, Masters of Family Medicine trainees commensals or contaminants [7,14]. Delaying antibiotics by 48 hours A case report form was developed to obtain relevant reduces their use and achieves similar, i. These guideline, which resembles British guidance [25], recommended nitrofurantoin, cefuroxime or co includes a diagnostic algorithm recommending empiric amoxiclav. Ciprofloxacin was only advised in antibiotic treatment in patients under 65 years with at pyelonephritis. Recommended duration of antibiotics least three typical symptoms, such as dysuria, was three-seven days in women, and at least seven days frequency, and urgency. Demographic characteristics of subjects with suspected in females), leucocytes (raised if > 3/? L in males, > urinary tract infection, in urban primary care in Malaysia, July 10/? Data on co-morbidities were extracted from the index consultation, the follow-up within eight weeks, and from consultations and investigations of the previous twelve months. The study received ethical approval from the University of Malaya Medical Centre Medical Ethics Committee. Results In total 852 consultations were retrieved, of which 366 were included (Figure 2). Symptoms recorded during consultations for suspected urinary tract infection, in urban primary care in Malaysia, July December 2016. From advance of follow-up appointments for hypertension or the 306 antibiotic prescriptions given in the clinic, 126 diabetes. The prescription of Antibiotics were prescribed in 307 consultations, ciprofloxacin was regarded as not following which was appropriate in 227/307 (73. Non on microscopy leucocytes and erythrocytes not raised pharmacological management included advice to and bacteria not seen). Inappropriate prescribing occurred either Urine culture was requested in 75/366 (20. Appropriateness of decision to prescribe antibiotics for suspected urinary tract infection, in urban primary care in Malaysia, July December 2016. Antibiotics given (307) Antibiotics not n (%) given (59) Appropriate to give antibiotics Symptomatic and raised leucocytes 227 (73. Requiring at not have considered this option, as it does not feature in least one symptom, and either leucocytes or nitrites on the Malaysian guideline [29], or maybe it seemed immediate urine testing, the study found 55/94 (58. The treatment was extensively used, though we note that for authors suggested some tests were unnecessary and led alkalinisers there is insufficient evidence to support to unnecessary antibiotics, which resembles our finding their use [35]. The the first-generation cephalosporin, cephalexin, was hypertension guideline [30] recommends testing for prescribed extensively though not recommended, while albuminuria or microalbuminuria, and checking for the second-generation cefuroxime, which is microsopic haematuria with respect to possible renal recommended, was used little. The diabetes guideline [31] recommends June 2016, just before our study period, the more testing for albuminuria or microalbuminuria, and expensive cefuroxime was not available for prescription advises annual urine microscopy. This patient management software, as demonstrated in suggests opportunities were missed to diagnose and Ireland [6]. We accepted It was recorded in English but appears to represent the one symptom only, but some definitions in the elderly Malay phrase ?tidak lawas? (personal communication [7] require at least two symptoms. G (2013) Toward a simple diagnostic index for acute Pitfalls included inappropriate antibiotic prescribing in uncomplicated urinary tract infections. The majority of antibiotics chosen Smith H, Hawke C, Mullee M (2006) Developing clinical rules were not recommended. Open Forum Infect Dis (2011) Antimicrobial management and appropriateness of 4: ofx207. National Institute for Health and Care Excellence (2016) Carrara V, Watthanaworawit W, Keereecharoen L, Antimicrobial Stewardship. Available: Hanboonkunupakarn B, Nosten F, McGready R (2015) the 225 Jackson et al. Ministry of Health Malaysia (2016) National antibiotic management in primary care. Ministry of Health Malaysia (2014) Protocol on antimicrobial Department of Primary Care Medicine, Faculty of Medicine, stewardship program in healthcare facilities. Symptoms of infection are usually watery diarrhea and abdominal cramps, but serious complications can result that require hospitalization and on rare occasions cause death. Click on the category of interest, and you will be directed to the resources available for that specific topic. Also discussed is the tiered response of prevention activities during routine and heightened infection prevention and control responses. As the title indicates this lecture provides information on prevention and treatment recommendations for long-term care facilities. It also includes recommendations for prevention, management of cases and infection control practices. Educational brochures, posters, fact sheets for patients and providers are available. The Ounce of Prevention Campaign is aimed at educating a broad consumer and professional audience. My daughter never heard of staphylococcus nity tried to calm fears by stressing the had the children monitor each other to Uaureus. Kudos to my health officials and the medical com daughter and to her school for imple munity remained calm. While this attention raised the infections such as common colds, alert for infection control practice, it flu, foodborne illness and others. The germ has caused ducted the decontamination used gowns and/or illness is early detection, early diag serious illnesses in healthcare organiza and self-contained breathing apparatus, nosis, proper treatment and follow up. With these stories circulating industry is acutely aware of these inci trators should be thinking about with throughout the media, the students could dents. In response to the 1999 munity were concerned about media cov She calmed the children by differenti ?To Err is Human? study, the birth of the erage that made it sound as though people ating the two issues. Many tions to participate in 100,000 Lives and tions that partnered with the ?100,000 studies have validated the fact that health Five Million Lives Saved projects, but Lives Campaign? monitored its data for care workers play a major role in spread they are all volunteer partners. Report cards are generated for each infections fits as a conduit to reduce not or even eradicated in several European participating organization to benchmark only healthcare-acquired infections, but healthcare systems. Focus on anticoagulants, seda implementing a series of interdependent, this new requirement has raised aware tives, narcotics and insulin. Initiatives recommended by the Surgical Care reliably delivering the correct periopera implemented include screening high-risk Improvement Project. High ?Deliver reliable, evidence-based ?Prevent ventilator-associated pneu risk patients may be patients transferred care for congestive heart failure to monia by implementing a series of inter reduce readmission. The protease the nose and can cause a range of illnesses activity of the exfoliative toxins causes Clinical Epidemiology from minor skin infections, such as pim peeling of the skin observed with staphy S. Infrequently, it may be found ness is early detection, early diagnosis, teria found inside. It is essential to obtain a full histo with infected patients, screening patients cumstances does not always indicate infec ry and to perform a physical, including admitted to hospitals has been found to tion and, therefore, does not always require checking skin for any infection.
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