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Twenty-five were chosen for inclusion in the evidence base. When multiple systematic reviews reported on the same outcome and included the same primary literature, only the most complete systematic review was retained.
All 20 excluded systematic reviews were excluded based on overlapping primary literature when compared to the systematic reviews chosen for inclusion in the evidence base. Search for Primary Literature The primary literature systematic review was used to address all outcomes not covered by the included systematic reviews. It was anticipated that primary literature would report on outcomes in addition to what was pooled in the 24 included systematic reviews.
As such, the literature search for primary literature was not altered following selection of the systematic review into the evidence base. Instead, where overlap was recognized between studies included in the identified systematic reviews and identified primary studies, primary studies were either removed from the evidence base, or when primary literature reported on additional outcomes, overlapping outcomes were not extracted in the primary literature.
This methodology ensured that data were not included twice in the evidence base, as this may result in an overestimate of effect. Literature Search Results The primary search returned 20, unique citations. Following a title and abstract screen, full texts were obtained for 3, studies. One hundred eight-four primary literature studies met the inclusion criteria and were included in the evidence base Figure 1.
An integral part of the guideline development process at the AUA is external peer review. Additionally, a call for reviewers was placed on the AUA website from May 26 — June 7, to allow any additional interested parties to request a copy of the document for review. The guideline was also sent to the Urology Care Foundation to open the document further to the patient perspective.
The draft guideline document was distributed to 34 peer reviewers. All peer review comments were blinded and sent to the Panel for review. In total, 23 reviewers provided comments, including 3 external reviewers.
At the end of the peer review process, a total of comments were received. Following comment discussion, the Panel revised the draft as needed. At initial evaluation, clinicians should identify patients as either: a. Clinical Principle. In addition to treating bothersome symptoms associated with NLUTD, the clinician needs to be aware of the various parameters that place patients at future risk for damage to the upper urinary tract.
This can be a challenge when managing NLUTD patients as there are a variety of neurologic diseases and insults that can result in NLUTD and, even within specific neurologic diagnoses, there is a spectrum of disease severity. The Panel strongly feels that clinicians who treat patients with NLUTD are able to assess their potential for risk and damage to the upper urinary tract and follow these patients accordingly based on this risk stratification Figure 2.
To a certain degree stratification can be done based on location of the neurologic disease or insult. For example, patients with suprapontine lesions e. However, elevated PVRs could be seen in certain patients after CVA or in patients with cerebral palsy and pseudodyssynergia; placing them in the moderate-risk category.
In addition, lesions distal to the spinal cord tend to have low bladder storage pressures; however, poor contractility could result in elevated PVRs and over time loss of bladder compliance can be seen in this patient population as well, another example of how lesion location can cross over into several risk stratification categories.
These patients would be placed in the unknown-risk category until further evaluation UDS, upper tract imaging, assessment of renal function is performed allowing for more specific stratification. These studies allow for evaluation for kidney abnormalities such as hydronephrosis or renal scarring, assessment of renal function and the presence of potentially concerning urodynamics findings such as poor bladder compliance, DO and DESD.
Once patients are appropriately stratified based on their evaluation Table 3 , the Panel has provided recommendations within the Guideline as to how these patients should undergo regular urologic surveillance. Patients are categorized into the highest risk strata they meet e. At initial evaluation, all patients with NLUTD should undergo a detailed history, physical exam, and urinalysis. NLUTD represents a broad spectrum of medical conditions and illnesses which result in variable effects to the lower urinary tract.
Although, to some degree, the individual clinical findings can be predicted by the neurological condition or illness, there are several factors which may preclude accuracy in the initial assessment.
Potential limitations of cognition, as well as motor and sensory deficits in some individuals with NLUTD, can make information gathering and physical examination challenging and time consuming.
Such limitations also may reduce the diagnostic and prognostic accuracy of the initial evaluation prompting additional studies. A thorough initial assessment including a comprehensive history, directed physical examination, and UA is critical in directing subsequent evaluation and management. Such an initial assessment will guide the clinician in forgoing, or pursuing, further studies such as imaging and multichannel UDS.
Critical elements of the history and physical examination in the individual with NLUTD are outlined below. Important and notable factors to elicit in this population, which may impact management, include: cognitive ability; upper and lower extremity function; spasticity and dexterity, which impacts the ability to do CIC; mobility; supportive environment; and prognosis from the neurological condition i.
Validated questionnaires including symptom assessment instruments e. OAB-q, NBSS may be administered to capture baseline data as well as assess for changes over time and response to interventions. Abnormalities should be interpreted in the context of the patients underlying condition, symptoms, and the presence or absence of a urinary catheter.
An initial abnormal dipstick UA may prompt a formal microscopic examination of the urine. Ultimately, the initial evaluation is part of the risk stratification process which may or may not lead to further investigations, such as urinary tract imaging or multichannel UDS, in some individuals. At initial evaluation, patients with NLUTD who spontaneously void should undergo post-void residual measurement.
PVR is defined as the volume of urine left in the bladder at the end of micturition. Although uncommon, a poorly compliant, low-capacity bladder, with or without vesicoureteral reflux VUR , may be associated with a low PVR but still carry a substantial risk to the upper urinary tract in the setting of a competent or fixed, non-relaxing bladder outlet. An elevated PVR which could potentially be associated with a clinically relevant abnormality or condition e.
PVR can be measured using several techniques including transabdominal bladder scanner, real-time US, or urethral catheterization. Although non-invasive, the accuracy of transabdominal US imaging for PVR may be compromised by several factors including body habitus obesity , prior lower abdominal or pelvic surgery, presence of ascites or pelvic cysts, and vaginal prolapse involving the bladder. Urethral catheterization is the most accurate method and provides an uncontaminated urine specimen for further study, but is also the most invasive.
A single elevated PVR may not be indicative of bladder emptying ability. An artifactually elevated PVR may result from rapid diuresis or psychogenic inhibition e. Thus, a suspected abnormally elevated PVR should be confirmed with a second measurement at another visit. Expert Opinion. Multiple adjunctive studies such as a voiding diary, pad test, and non-invasive uroflowmetry may be useful in the initial assessment of some individuals with NLUTD.
Due to the wide variety of neurological conditions, signs and symptoms, and severity at presentation, such studies are selectively utilized where they may provide additional diagnostic or prognostic information or direct clinical management. It is notable that there exists very little normative data for diary parameters in the neurogenic population. Furthermore, although it is widely used and advocated as a diagnostic, management, and outcomes assessment tool, there is only sparse literature supporting its use in patients with NLUTD.
The baseline diary can corroborate, or sometimes conflict, with the symptomatic data obtained during history taking and provides a unique data point to be integrated into the overall assessment and management of the patient. The diary also provides an assessment of functional bladder volume, which can be helpful in behavioral modification strategies as well as in interpreting and performing multichannel UDS studies.
Additionally, bladder volumes recorded on the diary may assist with subsequent management protocols, especially in patients with impaired bladder compliance and elevated filling pressures, as bladder volumes can be behaviorally adjusted to avoid upper urinary tract deterioration in these patients. Finally, subsequent diaries can also be used in follow-up to assess response to various types of treatments. The optimal duration for collecting such diary data in the non-neurogenic population has been suggested to be from days; however, very little information is available on the optimal diary duration.
In one study in the NLUTD population, a 3-day diary was considered to be reliable for most of the parameters of interest. The pad test is a noninvasive, inexpensive tool used to acquire objective data in confirming the diagnosis of incontinence, assessing its severity, and aiding in the treatment in some individuals with NLUTD. Methods range from a short provocative test to a hour pad test. Quantitative pad tests are used to measure the amount of urine leakage after executing either a standardized set of activities or a normal daily routine over a fixed time period e.
These tests can range from short time pad tests, which are done in the office, to home-based pad tests, which are typically longer in duration. Qualitative pad tests typically are utilized to detect the presence of UI when the diagnosis is in doubt or requires objective confirmation. Such tests utilize a colored dye, either administered directly into the bladder, given orally, or given parentally, which stains the urine a predetermined color allowing the examination of the pad to assess for the presence of urine leakage.
Overall, there is little data on the optimal type, duration, or utility of pad tests specifically in the NLUTD population. A non-invasive uroflow uroflowmetry integrates bladder function and bladder outlet function over time during a voiding event.
Normative values and specific patterns have been established in the non-neurogenic population, which are suggestive of various underlying urological conditions such as BOO, DU, Valsalva voiding, and intrinsic sphincteric deficiency. Abnormalities in this test are indicative of a significant dysfunction in the voiding phase of micturition.
There are no normative values established in the NLUTD population; importantly, this test cannot distinguish between an abnormally low flow-rate due to outlet obstruction or DU. Notably, a normal uroflowmetry study does not exclude a co-existing significant underlying abnormality. At initial evaluation, in patients with low-risk NLUTD, the clinician should not routinely obtain upper tract imaging, renal function assessment, or multichannel urodynamics.
The statement is supported by four observational studies Pizzi , Kim , Han , Kim with a very serious risk of bias when reporting on urodynamic findings, but evidence was not further downgraded for any domain. As noted previously in this Guideline, there are patients with NLUTD who can be characterized as low-risk for complications at the initial evaluation depending on a number of clinical factors, including a neurological diagnosis resulting in NLUTD Figure 2.
Characteristics of these patients include a neurological condition with a low potential for serious genitourinary complications e. In the absence of chronically elevated storage pressures, there is limited or no risk to the patient with respect to renal function. Upper urinary tract imaging and renal function studies in the low-risk NLUTD patient are very likely to be normal and not indicated at the initial evaluation in the absence of other mitigating factors Figure 2.
Not all patients with suprapontine lesions are considered low-risk. These patients are at unknown-risk and these findings should prompt further investigation as indicated. In low-risk patients, bladder function may or may not be impaired, and symptoms may or may not be present, but the underlying neurogenic vesicourethral dysfunction is not commonly associated with abnormally high-pressure storage of urine, such as that seen with impaired compliance.
Multichannel UDS, the diagnostic tool used to assess intravesical storage parameters, is invasive, expensive, uncomfortable, and a potentially morbid diagnostic study. In the initial evaluation of low-risk NLUTD, multichannel UDS are unlikely to add significant value as intravesical storage pressures are generally not elevated.
This study should be reserved for patients in whom the results would affect prognosis, change the diagnosis, or direct treatment, 23 or in those in whom additional urological pathology, such as suspected obstruction, would alter management.
At initial evaluation, in patients with unknown-risk NLUTD, the clinician should obtain upper tract imaging, renal function assessment, and multichannel urodynamics. This statement was supported by two observational studies Elmelund , Ozkan with an aggregate very serious risk of bias, but evidence was not further downgraded for any domain. This may be due to several factors such as the type of underlying neurological condition i.
Accurate risk stratification in these individuals is not possible without additional evaluations, which would include multichannel UDS and upper tract assessment, including functional tests and imaging.
An initial assessment with multichannel UDS will provide additional information to allow for accurate risk stratification in the NLUTD patients who are at unknown-risk at presentation. NLUTD patients who are not stratified by initial history, physical examination, PVR, and UA as low-risk should also undergo upper tract assessment with imaging and functional studies.
Prediction of upper tract deterioration in all but the low-risk NLUTD population is currently imprecise and somewhat vague. Furthermore, even after assessment with multichannel UDS, the exact DLPP and intravesical storage pressure at which the upper urinary tract is at risk is unclear.
Furthermore, there is no universally agreed upon value of abnormal bladder compliance although calculated values of less than Thus, even though multichannel UDS are essential in the evaluation of these unknown risk NLUTD patients, this should be accompanied by an upper tract assessment as well at the time of initial evaluation.
In the patient with an acute neurological event resulting in NLUTD, the clinician should perform risk stratification once the neurological condition has stabilized. Timely risk stratification in the NLUTD patient enables the clinician to counsel the patient with respect to their condition and proceed with an appropriate, cost effective, and efficient evaluation resulting in an accurate diagnosis, an assessment of prognosis, and that often directs treatment. In doing so, the clinician will avoid unnecessary and potentially morbid testing, such as multichannel UDS in those who would not benefit, while proceeding with an evaluation in those for whom it would have utility.
However, there are some individuals in whom an initial risk stratification should be delayed, particularly those with spinal shock and acute brain injury.
Following an acute neurological event to the brain e. The exact timing of the evaluation should be explored in a shared decision-making context between the patient and clinician. Spinal shock following acute SCI is generally characterized by a period of loss of neurologic activity below the level of injury, including absent somatic reflex activity and flaccid muscle paralysis.
This usually results in the urodynamic findings of detrusor areflexia and preserved sphincter tone. It may occur in partial or complete SCI and may last several days or months, and usually resolves in approximately months, but the duration can be as long as years. Recovery from spinal shock is manifest by the return of reflex bladder activity and lower extremity deep tendon reflexes.
The exact pathophysiology of spinal shock, as well as its resolution, is not well understood. Nevertheless, profound clinical and urodynamic changes occur during the spinal shock period. Similarly, a transient period of clinical evolution commonly results following acute brain injury such as ischemic or hemorrhagic stroke or blunt or penetrating head trauma usually attributed to a temporary period of cerebral edema.
Urodynamic investigations during this period may reveal detrusor areflexia. Following treatment and recovery from the acute event, reinvestigation with UDS weeks or months later may reveal considerable changes in the pattern of lower urinary tract dysfunction.
Thus, following acute spinal or brain injury, the clinical condition as well as the short-term changes are not prognostically valuable, nor are they reflective of the ultimate long-term neuro-urological diagnosis.
Risk stratification should not be performed during this period in these patients and should be postponed until the neurological condition and consequences have stabilized. Furthermore, neurological recovery during this period is variable and depends on the type, extent, and mechanism of injury; initial treatment; and many other factors. Thus, risk stratification prior to stabilization will not be clinically meaningful and moreover, may be misleading.
Similar to the general population, cystoscopy should be reserved for situations where there is a defined clinical indication or strong suspicion of an anatomic abnormality. Cystoscopy is an invasive, potentially morbid, expensive, and oftentimes uncomfortable diagnostic procedure. In the NLUTD patient, cystoscopy may be indicated at the initial evaluation in the setting of unexplained hematuria or pyuria; suspected urethral pathology such as stricture or false passage; bladder stones; or known or suspected bladder cancer.
However, in the absence of mitigating factors from history, physical examination, or UA, as noted above, lower urinary tract investigation with cystoscopy is unlikely to yield a significant finding in the NLUTD patient and is therefore not recommended. Cystoscopy may reveal abnormalities, such as trabeculation in some individuals with NLUTD, but these findings do not independently alter diagnosis, prognosis, or affect treatment and do not warrant investigation.
Furthermore, pharmacotherapy to manage AD should be accessible and readily available in the facility before every urologic procedure. The excessive compensatory parasympathetic activity leads to vasodilation above the level of the lesion and is thought to be responsible for headache, visual disturbances flushing, sweating, and nasal congestion. The reflex bradycardia is secondary to baroreceptor mediated vagal stimulation.
Bladder distension is the most common trigger factor for AD. It is important to note that the second most common trigger factor for AD is bowel distension due to fecal impaction. This can be noticed during placement of the rectal catheter at the time of multichannel UDS. Education of patients, clinicians, caregivers, and family members regarding AD is vital to prevent its occurrence, facilitate its recognition, and proceed with treatment in a timely fashion.
These maneuvers should be considered first-line treatment and are often the most expeditious and effective in treating the condition. Clinical improvement, as measured hemodynamically and clinically, is usually immediate once the noxious stimulus has been removed. Blood pressure should be monitored at least every five minutes until the patient is stable with baseline vital signs. If hemodynamic improvement does not occur after first-line treatment, then pharmacotherapy should be considered see Statement In general, nitrates are the most commonly used medication to manage refractory AD associated blood pressure elevation because they have a direct relaxant effect on vascular smooth muscles, leading to dilation of coronary vessels and peripheral veins.
Alternatively, nifedipine, a dihydropyridine, voltage-sensitive calcium channel blocker, can be used. When it is administered in immediate-release sublingual form 10 mg capsules , it exerts coronary and peripheral vasodilator properties. Also, nifedipine can rapidly and precipitously lower blood pressure well below baseline values and its effects may not be rapidly reversed in the clinic setting, as can be done with wiping topical nitroglycerine off, so it should be used judiciously.
If such antihypertensive compounds do not alleviate symptoms, then escalating care to an intensively monitored setting may be appropriate. Initiating intravenous administration of sodium nitroprusside may be indicated for rapid titration of blood pressure. Alpha-adrenergic receptor blocking agents e. Another alpha 1-adrenergic antagonist, prazosin 3 mg twice a day, given for 2 weeks , has been reported to reduce both the severity and duration of AD episodes in cervical and high thoracic SCI individuals.
The clinician must educate patients with NLUTD on the signs and symptoms that would warrant additional assessment. Patients with NLUTD can suffer from urological complications in the interval period between annual visits and, because of their neurological condition, may not have the expected signs and symptoms.
Patients should be educated to contact their clinician if they develop new or worsening AD or UI. Both could be early warnings of worsening bladder function such as DO or worsening bladder compliance.
Hematuria, even with catheterization, should be reported to their clinician since this can be an early sign of bladder cancer 56 or urinary lithiasis. The clinician may already have sufficient information from routine urologic care to assess the potential severity of the new signs and symptoms, and the decision to provide reassurance, investigations, or an office evaluation will be situation specific.
Although signs and symptoms can be atypical in this population, the importance of investigating them cannot be underestimated. Symptomatic NLUTD patients are far more likely to have pathologic findings than those without symptoms. In patients with low-risk NLUTD and stable urinary signs and symptoms, the clinician should not obtain surveillance upper tract imaging, renal function assessment, or multichannel urodynamics.
The evidence base for this statement is comprised of one systematic review Averbeck and two observational studies Pizzi , Kim The two observational studies reported on urodynamic parameters and were limited by a very serious risk of bias but evidence was not further downgraded. Low-risk NLUTD patients are by definition those with a neurological diagnosis that is low-risk to the upper urinary tract i. Because of their low-risk neurological conditions, these patients do not require upper tract imaging, renal function assessment, or UDS at initial presentation or in subsequent follow up Figure 2; Statement 4.
It is highly unlikely that over time these patients will develop urological complications secondary to their NLUTD; hence, there is little utility in performing more advanced screening tests. Also, should they develop a complication such as a renal stone, urinary retention, or a UTI, these conditions would present symptomatically and further evaluation could be done as indicated Figure 2.
These patients can suffer from non-neurological causes of LUTS, such as sling obstruction or BPH causing BOO, which can be treated based on clinical presentation, but often require greater counselling of the patient before treatment and potentially more workup, such as UDS, before proceeding with surgical intervention. None of these patients had dangerous findings such as poor bladder compliance, high storage pressures, or detrusor sphincter dyssynergia DSD , none of which would be expected with a suprapontine neurological disease.
The most frequent urodynamic finding in patients with PD is DO with balanced voiding; other findings include low PVR volumes, normal bladder compliance, and normal capacity without evidence of high-risk features. If low-risk patients develop new signs, symptoms, or complications during their follow-up period, risk re-stratification and appropriate evaluation can be done as indicated see Statement These patients, when appropriate, can be managed expectantly with follow-up by their primary care provider and with education on signs and symptoms that would require re-evaluation see Statement In patients with moderate-risk NLUTD and stable urinary signs and symptoms , the clinician should assess the patient with:.
This statement is informed by two systematic reviews Averbeck , Cameron and seven observational studies Cameron , Edokpolo , Guzelkucuk , Gao , Katsumi , Chen , Bartel reporting on detection of new or worsening symptoms.
The studies carried a very serious aggregate risk of bias but evidence was not further downgraded for any domain. An annual focused history, physical exam, and symptom assessment, with or without applicable questionnaires, provides the opportunity to screen for complications and worsening or new symptoms that may require investigation or a change in medical management Figure 1.
Patients who catheterize can be assessed for adherence to their recommended schedule or for difficulties in passage of their catheter. Renal function with serum creatinine, although a weak predictor of renal deterioration for many patients in this population with low muscle mass, 61 is a simple test and often is performed with other routine lab work obtained by other providers.
Serum creatinine levels in SCI patients have been shown to be significantly lower than age and gender matched ambulatory individuals; levels below the normal range are expected. A significant rise in serum creatinine from baseline, even within the normal range, should prompt careful assessment. Alternatively, a creatinine clearance measure by hour urine collections is more sensitive, but time consuming. Due to changes in sensation from their neurological disorder, renal calculi are often asymptomatic in moderate-risk NLUTD patients and symptoms of ureteral obstruction may present differently.
In addition, because these patients are at a higher risk of UTI, staghorn calculi and infectious stones are prevalent and can lead to serious complications if discovered late or when of substantial size. Renal US is a low morbidity imaging modality that assesses both the kidneys and bladder with better sensitivity for calculi than a kidney, ureter, and bladder X-ray KUB 61 and without the risk of ionizing radiation from CT scans.
If a patient has undergone cross sectional or other equivalent upper tract imaging for other purposes during the interval between visits, it would be adequate to reference this imaging. Nuclear medicine renal scans are a more sensitive assessment of renal obstruction than serum creatinine, intravenous pyelogram, or voiding cystourethrogram 61 and provide information on renal function; however, in studies on serial renal nuclear scans on individuals with SCI, there was no advantage over renal US, particularly if the renal US was normal.
A renal scan, which is more time-intensive than a renal US, is best reserved for investigating renal function deterioration based on serum creatinine, evaluating obstruction, or as a secondary imaging study if abnormalities are seen on renal US. Also, renal scans are poor at identifying renal stones and cannot be used as an alternative imaging to renal US.
Several systematic reviews support this surveillance schedule, particularly the use of routine renal US, 61 although actual clinical practice may differ. Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously. The cookie is used to store the user consent for the cookies in the category “Analytics”.
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Performance Performance. Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors. Suggestions for stopping rules have been made around the retrieval of new records, for example to stop if adding in a series of new terms to a database search strategy yields no new relevant records, or if precision falls below a particular cut-off point Chilcott et al Stopping might also be appropriate when the removal of terms or concepts results in missing relevant records.
Another consideration is the amount of evidence that has already accrued: in topics where evidence is scarce, authors might need to be more cautious about deciding when to stop searching. Although many methods have been described to assist with deciding when to stop developing the search, there has been little formal evaluation of the approaches Booth , Arber and Wood At a basic level, investigation is needed as to whether a strategy is performing adequately.
It is not enough, however, for the strategy to find only those records, otherwise this might be a sign that the strategy is biased towards known studies and other relevant records might be being missed. In addition, citation searches see online Technical Supplement Section 1. If those additional methods are finding documents that the searches have already retrieved, but that the team did not necessarily know about in advance, then this is one sign that the strategy might be performing adequately.
If some of the PRESS dimensions seem to be missing without adequate explanation or arouse concerns, then the search may not yet be complete. Statistical techniques can be used to assess performance, such as capture-recapture Spoor et al , Ferrante di Ruffano et al also known as capture-mark-recapture; Kastner et al , Lane et al , or the relative recall technique Sampson et al , Sampson and McGowan Kastner suggests the capture-mark-recapture technique merits further investigation since it could be used to estimate the number of studies in a literature prospectively and to determine where to stop searches once suitable cut-off levels have been identified.
This would entail potentially an iterative search and selection process. Capture-recapture needs results from at least two searches to estimate the number of missed studies. Further investigation of published prospective techniques seems warranted to learn more about the potential benefits.
Relative recall Sampson et al , Sampson and McGowan requires a range of searches to have been conducted so that the relevant studies have been built up by a set of sensitive searches. The performance of the individual searches can then be assessed in each individual database by determining how many of the studies that were deemed eligible for the evidence synthesis and were indexed within a database, can be found by the database search used to populate the synthesis.
If a search in a database did not perform well and missed many studies, then that search strategy is likely to have been suboptimal. If the search strategy found most of the studies that were available to be found in the database, then it was likely to have been a sensitive strategy.
Assessments of precision could also be made, but these mostly inform future search approaches since they cannot affect the searches and record assessment already undertaken. Relative recall may be most useful at the end of the search process since it relies on the achievement of several searches to make judgements about the overall performance of strategies. In evidence synthesis involving qualitative data, searching is often more organic and intertwined with the analysis such that the searching stops when new information ceases to be identified Booth The reasons for stopping need to be documented and it is suggested that explanations or justifications for stopping may centre around saturation Booth Further information on searches for qualitative evidence can be found in Chapter Review authors should document the search process in enough detail to ensure that it can be reported correctly in the review see MECIR Box 4.
The searches of all the databases should be reproducible to the extent that this is possible. By documenting the search process, we refer to internal record-keeping, which is distinct from reporting the search process in the review discussed in online Chapter III. Document the search process in enough detail to ensure that it can be reported correctly in the review.
The search process including the sources searched, when, by whom, and using which terms needs to be documented in enough detail throughout the process to ensure that it can be reported correctly in the review, to the extent that all the searches of all the databases are reproducible.
Suboptimal reporting of systematic review search activities and methods has been observed Sampson et al , Roundtree et al , Niederstadt and Droste Research has also shown a lack of compliance with guidance in the Handbook with respect to search strategy description in published Cochrane Reviews Sampson and McGowan , Yoshii et al , Franco et al The lack of consensus regarding optimal reporting has been a challenge with respect to the values of transparency and reproducibility.
These recommendations may influence record keeping practices of searchers. For Cochrane Reviews, the bibliographic database search strategies should be copied and pasted into an appendix exactly as run and in full, together with the search set numbers and the total number of records retrieved by each search strategy. The search strategies should not be re-typed, because this can introduce errors. The same process is also good practice for searches of trials registers and other sources, where the interface used, such as introductory or advanced, should also be specified.
Creating a report of the search process can be accomplished through methodical documentation of the steps taken by the searcher. This need not be onerous if suitable record keeping is performed during the process of the search, but it can be nearly impossible to recreate post hoc. Many database interfaces have facilities for search strategies to be saved online or to be emailed; an offline copy in text format should also be saved. For some databases, taking and saving a screenshot of the search may be the most practical approach Rader et al Documenting the searching of sources other than databases, including the search terms used, is also required if searches are to be reproducible Atkinson et al , Chow , Witkowski and Aldhouse Details about contacting experts or manufacturers, searching reference lists, scanning websites, and decisions about search iterations can be produced as an appendix in the final document and used for future updates.
The purpose of search documentation is transparency, internal assessment, and reference for any future update. It is important to plan how to record searching of sources other than databases since some activities contacting experts, reference list searching, and forward citation searching will occur later on in the review process after the database results have been screened Rader et al The searcher should record any correspondence on key decisions and report a summary of this correspondence alongside the search strategy in a search narrative.
The narrative describes the major decisions that shaped the strategy and can give a peer reviewer an insight into the rationale for the search approach Craven and Levay A worked example of a search narrative is available Cooper et al b. Local copies should be stored in a structured way to allow retrieval when needed. There are also web-based tools which archive webpage content for future reference, such as WebCite Eysenbach and Trudel The results of web searches will not be reproducible to the same extent as bibliographic database searches because web content and search engine algorithms frequently change, and search results can differ between users due to a general move towards localization and personalization Cooper et al b.
It is still important, however, to document the search process to ensure that the methods used can be transparently reported Briscoe In cases where a search engine retrieves more results than it is practical to screen in full it is rarely practical to search thousands of web results, as the precision of web searches is likely to be relatively low , the number of results that are documented and reported should be the number that were screened rather than the total number Dellavalle et al , Bramer Decisions should be documented for all records identified by the search.
Numbers of records are sufficient for exclusions based on initial screening of titles and abstracts. Broad categorizations are sufficient for records classed as potentially eligible during an initial screen of the full text. Authors will need to decide for each review when to map records to studies if multiple records refer to one study. The flow diagram records initially the total number of records retrieved from various sources, then the total number of studies to which these records relate.
Review authors need to match the various records to the various studies in order to complete the flow diagram correctly. Lists of included and excluded studies must be based on studies rather than records see also Section 4.
A Cochrane Review is a review of studies that meet pre-specified eligibility criteria. Since each study may have been reported in several articles, abstracts or other reports, an extensive search for studies for the review may identify many reports for each potentially relevant study.
Two distinct processes are therefore required to determine which studies can be included in the review. One is to link together multiple reports of the same study; and the other is to use the information available in the various reports to determine which studies are eligible for inclusion. Although sometimes there is a single report for each study, it should never be assumed that this is the case. As well as the studies that inform the systematic review, other studies will also be identified and these should be recorded or tagged as they are encountered, so that they can be listed in the relevant tables in the review:.
Duplicate publication can take various forms, ranging from identical manuscripts to reports describing different outcomes of the study or results at different time points von Elm et al The number of participants may differ in the different publications. Where uncertainties remain after considering these and other factors, it may be necessary to correspond with the authors of the reports. Multiple reports of the same study should be collated, so that each study, rather than each report, is the unit of interest in the review see MECIR Box 4.
Review authors will need to choose and justify which report the primary report to use as a source for study results, particularly if two reports include conflicting results. They should not discard other secondary reports, since they may contain additional outcome measures and valuable information about the design and conduct of the study.
Collate multiple reports of the same study, so that each study, rather than each report, is the unit of interest in the review. It is wrong to consider multiple reports of the same study as if they are multiple studies. Secondary reports of a study should not be discarded, however, since they may contain valuable information about the design and conduct.
Review authors must choose and justify which report to use as a source for study results. A typical process for selecting studies for inclusion in a review is as follows the process should be detailed in the protocol for the review :.
Note that studies should not be omitted from a review solely on the basis of measured outcome data not being reported see MECIR Box 4. Systematic reviews typically should seek to include all relevant participants who have been included in eligible study designs of the relevant interventions and had the outcomes of interest measured.
Reviews must not exclude studies solely on the basis of reporting of the outcome data, since this may introduce bias due to selective outcome reporting and risk undermining the systematic review process.
While such studies cannot be included in meta-analyses, the implications of their omission should be considered. Note that studies may legitimately be excluded because outcomes were not measured. Furthermore, issues may be different for adverse effects outcomes, since the pool of studies may be much larger and it can be difficult to assess whether such outcomes were measured. Decisions about which studies to include in a review are among the most influential decisions that are made in the review process and they involve judgement.
Use at least two people working independently to determine whether each study meets the eligibility criteria. Ideally, screening of titles and abstracts to remove irrelevant reports should also be done in duplicate by two people working independently although it is acceptable that this initial screening of titles and abstracts is undertaken by only one person. Use at least two people working independently to determine whether each study meets the eligibility criteria, and define in advance the process for resolving disagreements.
The inclusion decisions should be based on the full texts of potentially eligible studies when possible, usually after an initial screen of titles and abstracts.
It is desirable, but not mandatory, that two people undertake this initial screening, working independently. It has been shown that using at least two authors may reduce the possibility that relevant reports will be discarded Edwards et al , Waffenschmidt et al , Gartlehner et al although other case reports have suggested single screening approaches may be adequate Doust et al , Shemilt et al Opportunities for screening efficiencies seem likely to become available through promising developments in single human screening in combination with machine learning approaches O’Mara-Eves et al Experts in a particular area frequently have pre-formed opinions that can bias their assessment of both the relevance and validity of articles Cooper and Ribble , Oxman and Guyatt Thus, while it is important that at least one author is knowledgeable in the area under review, it may be an advantage to have a second author who is not a content expert.
Disagreements about whether a study should be included can generally be resolved by discussion. Often the cause of disagreement is a simple oversight on the part of one of the review authors. When the disagreement is due to a difference in interpretation, this may require arbitration by another person. Occasionally, it will not be possible to resolve disagreements about whether to include a study without additional information.
In these cases, authors may choose to categorize the study in their review as one that is awaiting assessment until the additional information is obtained from the study authors. A single failed eligibility criterion is sufficient for a study to be excluded from a review.
The eligibility criteria order may be different in different reviews and they do not always need to be the same.
For most reviews it will be worthwhile to pilot test the eligibility criteria on a sample of reports say six to eight articles, including ones that are thought to be definitely eligible, definitely not eligible and doubtful. The pilot test can be used to refine and clarify the eligibility criteria, train the people who will be applying them and ensure that the criteria can be applied consistently by more than one person. During the selection process it is crucial to keep track of the number of references and subsequently the number of studies so that a flow diagram can be constructed.
The decision and reasons for exclusion can be tracked using reference management software, a simple document or spreadsheet, or using specialist systematic review software see Section 4. Broad categorizations are sufficient for records classed as potentially eligible during an initial screen.
At least one explicit reason for their exclusion must be documented. Lists of included and excluded studies must be based on studies rather than records. This covers all studies that may, on the surface, appear to meet the eligibility criteria but which, on further inspection, do not.
It also covers those that do not meet all of the criteria but are well known and likely to be thought relevant by some readers. By listing such studies as excluded and giving the primary reason for exclusion, the review authors can show that consideration has been given to these studies. The list of excluded studies should be as brief as possible. It should not list all of the reports that were identified by an extensive search.
In particular, it should not list studies that are obviously not randomized if the review includes only randomized trials. An extensive search for eligible studies in a systematic review can often identify thousands of records that need to be manually screened. Selecting studies from within these records can be a particularly time-consuming, laborious and logistically challenging aspect of conducting a systematic review. Software to support the selection process, along with other stages of a systematic review, including text mining tools, can be identified using the Systematic Review Toolbox.
The SR Toolbox is a community driven, web-based catalogue of tools that provide support for systematic reviews Marshall and Brereton Managing the selection process can be challenging, particularly in a large-scale systematic review that involves multiple reviewers. Basic productivity tools can help such as word processors, spreadsheets, and reference management software , and several purpose-built systems that support multiple concurrent users are also available that offer support for the study selection process.
Software for managing the selection process can be identified using the Systematic Review Toolbox mentioned above. Compatibility with other software tools used in the review process such as RevMan may be a consideration when selecting a tool to support study selection. Should specialist software not be available, Bramer and colleagues have developed a method for using the widely available software EndNote X7 for managing the screening process Bramer et al Research into automating the study selection process through machine learning and text mining has received considerable attention over recent years, resulting in the development of various tools and techniques for reviewers to consider.
The use of automated tools has the potential to reduce the workload involved with selecting studies significantly Thomas et al Cochrane has also implemented a screening workflow called Screen4Me. Cochrane author teams conducting intervention reviews that incorporate RCTs can access this workflow via the Cochrane Register of Studies. To date January , Screen4Me has been used in over 50 Cochrane intervention reviews. Workload reduction in terms of screening burden varies depending on the prevalence of RCTs in the domain area and the sensitivity of the searches conducted.
In addition to learning from large datasets such as those generated by Cochrane Crowd, it is also possible for machine learning models to learn how to apply eligibility criteria for individual reviews. It is difficult for authors to determine in advance when it is safe to stop screening and allow some records to be eliminated automatically without manual assessment. Recent work has suggested that this barrier is not insurmountable, and that it is possible to estimate how many relevant records remain to be found based on the sample already screened Sneyd and Stevenson , Callaghan and Muller-Hansen , Li and Kanoulas The automatic elimination of records using this approach has not been recommended for use in Cochrane Reviews at the time of writing.
This active learning process can still be useful, however, since by prioritizing records for screening in order of relevance, it enables authors to identify the studies that are most likely to be included much earlier in the screening process than would otherwise be possible.
Finally, tools are available that use natural language processing to highlight sentences and key phrases automatically e. PICO elements, trial characteristics, details of randomization to support the reviewer whilst screening Tsafnat et al Many of the sources listed in this chapter and the accompanying online Technical Supplement have been brought to our attention by a variety of people over the years and we should like to acknowledge this.
Evidence Based Library and Information Practice ; 14 : Agency for Healthcare Research and Quality. Methods guide for effectiveness and comparative effectiveness reviews: AHRQ publication no.
Annotated bibliography of published studies addressing searching for unpublished studies and obtaining access to unpublished data.
Arber M, Wood H. Search strategy development [webpage]. Reporting standards for literature searches and report inclusion criteria: making research syntheses more transparent and easy to replicate.
Research Synthesis Methods ; 6 : Alimentary Pharmacology and Therapeutics ; 26 : ; author reply Impact of searching clinical trial registries in systematic reviews of pharmaceutical treatments: methodological systematic review and reanalysis of meta-analyses. BMJ ; : j Bennett DA, Jull A. FDA: untapped source of unpublished trials. Lancet ; : A cross-sectional audit showed that most Cochrane intervention reviews searched trial registers.
Journal of Clinical Epidemiology ; : Bero L. Searching for unpublished trials using trials registers and trials web sites and obtaining unpublished trial data and corresponding trial protocols from regulatory agencies. Booth A. How much searching is enough? Comprehensive versus optimal retrieval for technology assessments. Searching for qualitative research for inclusion in systematic reviews: a structured methodological review.
Systematic Reviews ; 5 : The “realist search”: A systematic scoping review of current practice and reporting. Research Synthesis Methods ; 11 : Bramer WM. Variation in number of hits for complex searches in Google Scholar. Journal of the Medical Library Association ; : Reviewing retrieved references for inclusion in systematic reviews using EndNote. Challenges in systematic reviews: synthesis of topics related to the delivery, organization, and financing of health care.
Annals of Internal Medicine ; : Briscoe S. A review of the reporting of web searching to identify studies for Cochrane systematic reviews. Research Synthesis Methods ; 9 : Identifying additional studies for a systematic review of retention strategies in randomised controlled trials: making contact with trials units and trial methodologists. Systematic Reviews ; 6 : Statistical stopping criteria for automated screening in systematic reviews.
Systematic Reviews ; 9 : Callaway J. Journal of Health Information and Libraries Australasia ; 2 : Center for Drug Evaluation and Research. Auto Injector. Centre for Reviews and Dissemination. Systematic Reviews: CRD’s guidance for undertaking reviews in health care. York: University of York; Chan AW. Out of sight but not out of mind: how to search for unpublished clinical trial evidence. BMJ ; : d Discontinuation and non-publication of surgical randomised controlled trials: observational study.
BMJ ; : g The role of modelling in prioritising and planning clinical trials. Health technology assessment Winchester, England ; 7 : iii, Chow TK.
Electronic search strategies should be repeatable.
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