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Background: Bezafibrate (BZF) alone or in combination with ursodeoxycholic acid (UDCA) has been used to slow disease progression in patients with primary biliary cholangitis (PBC). We performed a systematic review and meta-analysis to assess the efficacy and harms of BZF monotherapy or combination therapy. Methods: We performed a systematic search of PubMed, EMBASE, Cochrane Library, Scopus, ClinicalTrials.gov, and WHO ICTRP from inception until January 2020, for randomized controlled clinical trials assessing BZF + UDCA versus UDCA monotherapy or BZF monotherapy versus UDCA monotherapy in PBC patients. Additionally, we systematically evaluated data on harms using seven observational studies. Pooled effect estimates were calculated for the outcomes of interest. The certainty of evidence was assessed using GRADE (Grading of Recommendations Assessment, Development and Evaluation). Results: We identified 7 randomized controlled trials with a total of 279 participants. Comparing BZF + UDCA to UDCA alone, a clinically significant improvement was observed in serum ALP with a mean difference (MD) of − 159.04 U/L (95% CI − 186.45 to − 131.62) and a reduction in gamma-glutamyltransferase (GGT) (MD − 106.94 IU/L; 95% CI − 151.99 to − 61.89), but not in total bilirubin (TB) or IgM levels. A statistically significant reduction in ALP levels was also noticed with BZF monotherapy compared to UDCA monotherapy. The effect of BZF + UDCA versus UDCA on mortality remains unclear. Across 5 observational studies including 106 patients, one death was reported due to advanced liver disease in an incomplete responder getting treatment with BZF + UDCA. Analysis of observational studies demonstrated improvement in pruritus intensity with BZF. Conclusions: Use of BZF alone or in combination with UDCA improved liver biochemistries in patients with PBC, but its effect on mortality, liver-related complications or quality of life remains unknown. [ABSTRACT FROM AUTHOR]

Background: The development of rigorous, high-quality clinical guidelines increases the need for resources and skilled personnel within guideline-producing organizations. While collaboration between organizations provides a unique opportunity to pool resources and save time and effort, the collaboration presents its own unique challenges. Objective: To assess the perceived needs and current challenges of guideline producers worldwide related to guideline development and collaboration efforts. Design: Survey questions were developed by the Guidelines International Network and the US GRADE Network, pilot-tested among attendees of a guideline development workshop, and disseminated electronically using convenience and snowball sampling methods. Participants: A total of 171 respondents representing 30 countries and more than 112 unique organizations were included in this analysis. Main Measures: The survey included free-response, multiple-choice, and seven-point Likert-scale questions. Questions assessed respondents' perceived value of guidelines, resource availability and needs, guideline development processes, and collaboration efforts of their organization. Key Results: Time required to develop high-quality systematic reviews and guidelines was the most relevant need (median=7; IQR=5.5–7). In-house resources to conduct literature searches (median=4; IQR=3–6) and the resources to develop rigorous guidelines rapidly (median=4; IQR=2–5) were perceived as the least available resources. Difficulties reconciling differences in guideline methodology (median=6; IQR=4–7) and the time required to establish collaborative agreements (median=6; IQR=5–6) were the most relevant barriers to collaboration between organizations. Results also indicated a general need for improvement in conflict of interest (COI) disclosure policies. Conclusion: The survey identified organizational challenges in supporting rigorous guideline development, including the time, resources, and personnel required. Connecting guideline developers to existing databases of high-quality systematic reviews and the use of freely available online platforms may facilitate guideline development. Guideline-producing organizations may also consider allocating resources to hiring or training personnel with expertise in systematic review methodologies or utilizing resources more effectively by establishing collaborations with other organizations. [ABSTRACT FROM AUTHOR]

To assess the panel composition of the 2 most important guideline developers in urology as equity and acceptability, important domains in clinical guideline development, require broad stakeholder representation. Following a predefined protocol, we identified all current AUA and EAU guideline documents. Two authors independently abstracted data including guideline topic, number and roles of panel members, voting status, and academic rank. We determined panel member's gender (woman, man, or nonbinary) and racialization (White or non-White) status based on name, internet picture, pronouns used, bios available, and gender listed on their profile. We identified 31 AUA and 20 EAU guidelines for inclusion. Median panel size was 19 (interquartile range [IQR]: 17; 21) with 12 (IQR: 10; 14) voting members. The average composition of voting panels was predominantly male (81.8%) and White (86.8%). Eleven guideline panels (21.6%) did not include any women, and 9 (17.6%) panels had no representation of individuals from non-White groups. While gender distribution was similar among guidelines of the 2 organizations, the AUA included more voting members from non-White groups (14.3% vs 8.0%; P =.010). Analysis of the AUA panel composition over time revealed stable proportions of female and non-White individuals. Both AUA and EAU guidelines exhibit insufficient representation of females and non-White individuals, with no evident improvement observed over time. Implementing more transparent processes that advocate for diverse panel representation may enhance the incorporation of stakeholder values and preferences, thereby improving the dissemination and adoption of guidelines. [ABSTRACT FROM AUTHOR]

Background: There is increasing requirement to develop guidelines using transparent, standardized, and rigorous methods. Consequently, a better understanding of the knowledge, skills, and expertise necessary for guideline development is needed. The aim of this manuscript is to describe a theoretical framework of knowledge and skills that are required for individuals to serve on a guideline panel in varying capacities.Methods: Based on an iterative process and review of published manuscripts focused on guideline development, we identified competencies, subcompetencies, and milestones.Results: Using a competency-based approach to training and the Dreyfus model of skill acquisition, we identified three core competencies: (1) facilitate the development of guideline structure and setup, (2) make judgments about the quality or certainty of the evidence, and (3) transform evidence to a recommendation. Level 1 focuses on recognizing and acknowledging the importance of a specific skill or behavior. Levels 2 and 3 require learners to demonstrate progressive acquisition of knowledge and application to specific behaviors. Level 4 represents the individual who has acquired the requisite knowledge and can function independently, while level 5 represents the mastery/aspirational level.Discussion: We propose a preliminary competency-based education framework that will (1) help standardize the qualifications needed for individuals to serve on guideline panels in varying capacities or (2) help with curricula development for teaching and training of guideline panel members. This framework can also help enable guideline-producing organizations to identify guideline methodologists with the relevant and appropriate level of knowledge and skills to lead guidelines. Validation of the framework and further refinement of the competencies and milestones will be required before widespread adoption. [ABSTRACT FROM AUTHOR]

Background: A recommendation to undergo a colonoscopy, an invasive procedure that requires commitment and motivation, planning (scheduling and finding a driver) and preparation (diet restriction and laxative consumption), may be uniquely challenging for individuals with multiple chronic conditions (MCCs). This qualitative study aimed to describe the barriers and facilitators to colonoscopy experienced by such patients. Materials and methods: Semistructured focus groups were conducted with male Veterans who were scheduled for outpatient colonoscopy and either failed to complete the procedure or completed the examination. Focus group recordings were transcribed and analyzed by an inductive grounded approach using constant comparative analysis. Results: Forty-four individuals aged 51-83 years participated in this study (23 adherent and 21 nonadherent). Participants had an average of 7.4 chronic conditions (range 2-14). The five most common chronic conditions were hypertension (75%), hyperlipidemia (75%), osteoarthritis/degenerative joint disease (59%), atherosclerotic heart disease (48%), and diabetes mellitus (36%). We identified four unique themes that influenced motivation to undergo a colonoscopy: competing medical priorities, low perceived benefit, a prior negative colonoscopy experience, and pre-existing medical conditions. Additionally, we identified four themes that influenced individuals' ability to complete the examination: difficulty with bowel cleansing, difficulty with travel, worry about exacerbation of pre-existing conditions, and heightened concerns about potential complications. Conclusion: MCCs are common in individuals referred for colonoscopy and generate unique barriers to colonoscopy completion related to medication, dietary changes, transportation, preparation processes, symptoms exacerbation, and complication concerns. Future research should examine whether tailored interventions that include education and support in addressing the unique barriers can enhance colonoscopy completion. [ABSTRACT FROM AUTHOR]

The article discusses the results of a single-center study made on young patients at a U.S. Veterans Affairs Medical Center who were screened for colorectal cancer (CRC) from October 1, 1996 to March 30, 2004. Young patients with reduced life expectancy are being screened for CRC at relatively high rates. Fifty-two patients who were screened for CRC died during the 5-year follow-up.

Background We sought to assess the effectiveness and harms of initial treatment strategies for stage I through III anal squamous cell anal cancer. Methods We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials between January 1, 2000, and March 2024, for randomized controlled trials and nonrandomized studies of interventions comparing initial treatment strategies. Individual study risk of bias and overall strength of evidence were evaluated for a prespecified outcome list using standardized methods. Results We identified 33 eligible studies and extracted data. Six were deemed low to moderate risk of bias. Compared with radiation therapy alone, chemoradiation therapy (CRT) with 5-fluorouracil (5-FU) and mitomycin C probably shows a benefit in locoregional failure, disease-specific survival, and colostomy-free survival (moderate strength of evidence) yet may result in greater overall and acute hematological toxicity, with no difference in late harms (low strength of evidence). CRT with 5-FU plus mitomycin C may show a benefit in locoregional failure, disease-specific survival, and colostomy-free survival rates compared with 5-FU alone (low strength of evidence). CRT with 5-FU plus cisplatin vs 5-FU plus mitomycin C probably results in no differences in several effectiveness outcomes or overall acute or late harms and probably increases hematological toxicity with mitomycin C (moderate strength of evidence). Compared with CRT using capecitabine plus mitomycin C, CRT with capecitabine plus mitomycin C and paclitaxel may improve overall survival, disease-specific survival, and colostomy-free survival yet cause more acute harms (low strength of evidence). Evidence was insufficient for remaining comparisons. Conclusions CRT with 5-FU plus mitomycin C or 5-FU plus cisplatin is likely more effective yet incurs greater acute hematological toxicity than radiation therapy alone or single-agent CRT. Adding paclitaxel to capecitabine plus mitomycin C may increase treatment efficacy and toxicity. Evidence is insufficient comparing posttreatment surveillance strategies and patient-reported outcomes, highlighting research opportunities. [ABSTRACT FROM AUTHOR]

Many racial and ethnic minorities are at greater risk for chronic disease and worse outcomes. This evidence map systematically categorizes studies published between January 2017 and April 2024 according to the type, target, and setting of the intervention; the outcome measured; and the patient population. The evidence map can be used to highlight areas for future research. Background: Racial and ethnic disparities in health and health care persist in the United States, adversely affecting outcomes in prevention and treatment of chronic conditions among adults. Purpose: To map interventions aimed at reducing racial and ethnic disparities and improving health outcomes in the prevention and treatment of chronic conditions in adults. Data Sources: Searches of MEDLINE, CINAHL, and Scopus from January 2017 to April 2024, supplemented with gray literature. Study Selection: U.S.-based studies of interventions targeting racial and ethnic disparities in adults with chronic conditions. Data Extraction: Information on intervention types, targets, outcomes, study designs, study settings, chronic conditions, and delivery personnel was extracted and categorized. Data Synthesis: Among 174 unique studies, 12 intervention types were identified, with self-management support and patient navigation the most common. Most interventions targeted patient behaviors; few studies addressed disparities directly or focused on underrepresented racial and ethnic marginalized groups. Limitations: The lack of standardized terminology and the underrepresentation of certain racial and ethnic groups limit the evidence base. Although the literature search accurately reflects the current state of the literature, it also limits the body of evidence by excluding health disparities research conducted before January 2017, so significant findings from earlier studies may have been overlooked. Conclusion: The literature highlights diverse interventions targeting health disparities, but few studies evaluated their effectiveness in reducing the health disparities gaps. There is an urgent need for research focused on underrepresented racial and ethnic groups, particularly in promising areas such as patient navigation for cancer and diabetes self-management. Future research should prioritize robust study designs to assess the long-term effect and broader applicability of interventions, thus helping organizations and stakeholders to tailor strategies to community-specific needs. Primary Funding Source: Agency for Healthcare Research and Quality. [ABSTRACT FROM AUTHOR]

The article presents questions and answers related to anorectal disorders including chronic constipation, severe anal pain, and increasing water intake and dietary fiber.

The article presents a quiz in which questions asked related to colorectal cancer (CRC); screening colonoscopy; and advanced colorectal polyps.

Artificial intelligence–based image analysis technology has been developed for colonoscopy. In fact, adding computer-aided detection (CADe) to standard colonoscopy has been shown in several trials to improve overall colon polyp detection. However, whether the improved detection applies to high-risk or advanced polyps is unclear. The objective of this systematic review and meta-analysis was to compare the performance of CADe-enhanced and conventional colonoscopy. Background: Randomized clinical trials (RCTs) of computer-aided detection (CADe) system–enhanced colonoscopy compared with conventional colonoscopy suggest increased adenoma detection rate (ADR) and decreased adenoma miss rate (AMR), but the effect on detection of advanced colorectal neoplasia (ACN) is unclear. Purpose: To conduct a systematic review to compare performance of CADe-enhanced and conventional colonoscopy. Data Sources: Cochrane Library, Google Scholar, Ovid EMBASE, Ovid MEDLINE, PubMed, Scopus, and Web of Science Core Collection databases were searched through February 2024. Study Selection: Published RCTs comparing CADe-enhanced and conventional colonoscopy. Data Extraction: Average adenoma per colonoscopy (APC) and ACN per colonoscopy were primary outcomes. Adenoma detection rate, AMR, and ACN detection rate (ACN DR) were secondary outcomes. Balancing outcomes included withdrawal time and resection of nonneoplastic polyps (NNPs). Subgroup analyses were done by neural network architecture. Data Synthesis: Forty-four RCTs with 36 201 cases were included. Computer-aided detection–enhanced colonoscopies have higher average APC (12 090 of 12 279 [0.98] vs. 9690 of 12 292 [0.78], incidence rate difference [IRD] = 0.22 [95% CI, 0.16 to 0.28]) and higher ADR (7098 of 16 253 [44.7%] vs. 5825 of 15 855 [36.7%], rate ratio [RR] = 1.21 [CI, 1.15 to 1.28]). Average ACN per colonoscopy was similar (1512 of 9296 [0.16] vs. 1392 of 9121 [0.15], IRD = 0.01 [CI, −0.01 to 0.02]), but ACN DR was higher with CADe system use (1260 of 9899 [12.7%] vs. 1119 of 9746 [11.5%], RR = 1.16 [CI, 1.02 to 1.32]). Using CADe systems resulted in resection of almost 2 extra NNPs per 10 colonoscopies and longer total withdrawal time (0.53 minutes [CI, 0.30 to 0.77]). Limitation: Statistically significant heterogeneity in quality and sample size and inability to blind endoscopists to the intervention in included studies may affect the performance estimates. Conclusion: Computer-aided detection–enhanced colonoscopies have increased APC and detection rate but no difference in ACN per colonoscopy and a small increase in ACN DR. There is minimal increase in procedure time and no difference in performance across neural network architectures. Primary Funding Source: None. (PROSPERO: CRD42023422835) [ABSTRACT FROM AUTHOR]

Objective: To systematically analyze the wording of American Urological Association (AUA) clinical practice guidelines' recommendations.Materials and Methods: We systematically identified all AUA guideline documents that used the current AUA framework and extracted the individual recommendations, their statement type, and their corresponding evidence level (if applicable), and analyzed the recommendation wording separating out the modal verbs (eg, should, may, or must) as well as the main verbs (eg, recommend, treat, perform). We performed descriptive statistics using SPSS Version 27.Results: We included 18 documents with 754 distinct recommendations; the median number of recommendations per guideline was 36 (interquartile range: 29; 48.5). Expert opinion was the most used statement type (193; 25.6%), followed by clinical principle (156; 20.7%). Four-hundred-four recommendations were either strong, moderate, or conditional: 135 (17.9%), 187 (24.8%) and 83 (11.0%), respectively. Most recommendation statements (701; 93.0%) used modal verbs to express a level of obligation. Overall, "should" was the most employed modal verb used (73.9%), followed by "may" (17.6%) and "must" (1.5%). Both "may" and "should" were used in conjunction with all five statement types, whereas "must" was limited to strong recommendations and clinical principles.Conclusion: The wording of AUA recommendation statements does not signal the strength of recommendation and the intended level of obligation, which may represent a barrier to guideline implementation. More consistent wording of recommendations by strength may improve guideline understanding, uptake, and adherence. [ABSTRACT FROM AUTHOR]

Small polyps found in the distal colon during colonoscopy are often nonneoplastic. However, the visual features of these polyps are not reliable for distinguishing them from neoplastic adenomatous polyps. Computer-aided diagnosis (CADx) is an artificial intelligence–based image analysis technology designed to integrate with colonoscopy to determine whether a polyp is nonneoplastic and thus does not require removal. The objective of this systematic review and meta-analysis was to evaluate existing studies reporting on the diagnostic performance of CADx when used during colonoscopy. Background: Computer-aided diagnosis (CADx) allows prediction of polyp histology during colonoscopy, which may reduce unnecessary removal of nonneoplastic polyps. However, the potential benefits and harms of CADx are still unclear. Purpose: To quantify the benefit and harm of using CADx in colonoscopy for the optical diagnosis of small (≤5-mm) rectosigmoid polyps. Data Sources: Medline, Embase, and Scopus were searched for articles published before 22 December 2023. Study Selection: Histologically verified diagnostic accuracy studies that evaluated the real-time performance of physicians in predicting neoplastic change of small rectosigmoid polyps without or with CADx assistance during colonoscopy. Data Extraction: The clinical benefit and harm were estimated on the basis of accuracy values of the endoscopist before and after CADx assistance. The certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework. The outcome measure for benefit was the proportion of polyps predicted to be nonneoplastic that would avoid removal with the use of CADx. The outcome measure for harm was the proportion of neoplastic polyps that would be not resected and left in situ due to an incorrect diagnosis with the use of CADx. Histology served as the reference standard for both outcomes. Data Synthesis: Ten studies, including 3620 patients with 4103 small rectosigmoid polyps, were analyzed. The studies that assessed the performance of CADx alone (9 studies; 3237 polyps) showed a sensitivity of 87.3% (95% CI, 79.2% to 92.5%) and specificity of 88.9% (CI, 81.7% to 93.5%) in predicting neoplastic change. In the studies that compared histology prediction performance before versus after CADx assistance (4 studies; 2503 polyps), there was no difference in the proportion of polyps predicted to be nonneoplastic that would avoid removal (55.4% vs. 58.4%; risk ratio [RR], 1.06 [CI, 0.96 to 1.17]; moderate-certainty evidence) or in the proportion of neoplastic polyps that would be erroneously left in situ (8.2% vs. 7.5%; RR, 0.95 [CI, 0.69 to 1.33]; moderate-certainty evidence). Limitation: The application of optical diagnosis was only simulated, potentially altering the decision-making process of the operator. Conclusion: Computer-aided diagnosis provided no incremental benefit or harm in the management of small rectosigmoid polyps during colonoscopy. Primary Funding Source: European Commission. (PROSPERO: CRD42023402197) [ABSTRACT FROM AUTHOR]

IDSA Disclaimer As of the time of this publication, updates have been made to IDSA's Guidelines on the Diagnosis of COVID-19. For the most updated version of these guidelines, please go to https://www.idsociety.org/covid19guidelines. Background Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19). Direct detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in respiratory tract specimens informs patient, healthcare institution, and public health–level decision-making. The number of available SARS-CoV-2 nucleic acid detection tests is rapidly increasing, as is the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) recognized a significant need for frequently updated systematic reviews of the literature to inform evidence-based best practice guidance. Objective The IDSA's goal was to develop an evidence-based diagnostic guidelines to assist clinicians, clinical laboratorians, patients, and policy makers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, the society provides a conceptual framework for understanding molecular diagnostic test performance, discusses the nuance of test result interpretation in a variety of practice settings, and highlights important unmet research needs in the COVID-19 diagnostic testing arena. Methods IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. Grading of Recommendations Assessment, Development and Evaluation methodology was used to assess the certainty of evidence and make testing recommendations. Results The panel agreed on 15 diagnostic recommendations. Conclusions Universal access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention, and the public response to the COVID-19 pandemic. Information on the clinical performance of available tests is rapidly emerging, but the quality of evidence of the current literature is considered low to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is recommended for asymptomatic individuals who have had a known or suspected contact with a COVID-19 case. Testing asymptomatic individuals without known exposure is suggested when the results will impact isolation/quarantine/personal protective equipment usage decisions, dictate eligibility for surgery, or inform administration of immunosuppressive therapy. Ultimately, prioritization of testing will depend on institution-specific resources and the needs of different patient populations. [ABSTRACT FROM AUTHOR]

Background There are many pharmacologic therapies that are being used or considered for treatment of coronavirus disease 2019 (COVID-19). There is a need for frequently updated practice guidelines on their use, based on critical evaluation of rapidly emerging literature. The objective was to develop evidence-based rapid guidelines intended to support patients, clinicians, and other healthcare professionals in their decisions about treatment and management of patients with COVID-19. Methods The Infectious Diseases Society of America (IDSA) formed a multidisciplinary guideline panel of infectious disease clinicians, pharmacists, and methodologists with varied areas of expertise. Process followed a rapid recommendation checklist. The panel prioritized questions and outcomes. Then a systematic review of the peer-reviewed and gray literature was conducted. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence and make recommendations. Results The IDSA guideline panel agreed on 7 treatment recommendations and provided narrative summaries of other treatments undergoing evaluations. Conclusions The panel expressed the overarching goal that patients be recruited into ongoing trials, which would provide much-needed evidence on the efficacy and safety of various therapies for COVID-19, given that we could not make a determination whether the benefits outweigh harms for most treatments. [ABSTRACT FROM AUTHOR]

Background The availability of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serologic testing has rapidly increased. Current assays use a variety of technologies, measure different classes of immunoglobulin or immunoglobulin combinations, and detect antibodies directed against different portions of the virus. The overall accuracy of these tests, however, has not been well defined. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the coronavirus disease 2019 (COVID-19) serology literature and construct best-practice guidance related to SARS-CoV-2 serologic testing. This guideline is the fourth in a series of rapid, frequently updated COVID-19 guidelines developed by IDSA. Objective IDSA's goal was to develop evidence-based recommendations that assist clinicians, clinical laboratories, patients, and policymakers in decisions related to the optimal use of SARS-CoV-2 serologic tests in a variety of settings. We also highlight important unmet research needs pertaining to the use of anti–SARS-CoV-2 antibody tests for diagnosis, public health surveillance, vaccine development, and the selection of convalescent plasma donors. Methods A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review identified and prioritized clinical questions related to the use of SARS-CoV-2 serologic tests. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. Results The panel agreed on 8 diagnostic recommendations. Conclusions Information on the clinical performance and utility of SARS-CoV-2 serologic tests is rapidly emerging. Based on available evidence, detection of anti–SARS-CoV-2 antibodies may be useful for confirming the presence of current or past infection in selected situations. The panel identified 3 potential indications for serologic testing, including (1) evaluation of patients with a high clinical suspicion for COVID-19 when molecular diagnostic testing is negative and ≥2 weeks have passed since symptom onset, (2) assessment of multisystem inflammatory syndrome in children, and (3) conducting serosurveillance studies. The certainty of available evidence supporting the use of serology for either diagnosis or epidemiology was, however, graded as very low to moderate. For the most updated version of these guidelines, please go to https://www.idsociety.org/covid19guidelines. [ABSTRACT FROM AUTHOR]

Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a highly transmissible virus that can infect healthcare personnel (HCP) and patients in healthcare settings. Specific care activities, in particular, aerosol-generating procedures, may have a higher risk of transmission. The rapid emergence and global spread of SARS-CoV-2 has created significant challenges in healthcare facilities, particularly with severe shortages of personal protective equipment (PPE) used to protect HCP. Evidence-based recommendations for what PPE to use in conventional, contingency, and crisis standards of care are needed. Where evidence is lacking, the development of specific research questions can help direct funders and investigators. Objective Our objective was to develop evidence-based rapid guidelines intended to support HCP in their decisions about infection prevention when caring for patients with suspected or known coronavirus disease 2019 (COVID-19). Methods The Infectious Diseases Society of America (IDSA) formed a multidisciplinary guideline panel that included front-line clinicians, infectious diseases specialists, experts in infection control, and guideline methodologists with representation from the disciplines of preventive care, public health, medical microbiology, pediatrics, critical care medicine, and gastroenterology. The process followed a rapid recommendation checklist. The panel prioritized questions and outcomes. Then, a systematic review of the peer-reviewed and gray literature was conducted. The Grading of Recommendations Assessment, Development and Evaluation approach was used to assess the certainty of evidence and make recommendations. Results The IDSA guideline panel agreed on 8 recommendations and provided narrative summaries of other interventions undergoing evaluations. Conclusions Using a combination of direct and indirect evidence, the panel was able to provide recommendations for 8 specific questions on the use of PPE for HCP who provide care for patients with suspected or known COVID-19. Where evidence was lacking, attempts were made to provide potential avenues for investigation. Significant gaps in the understanding of the transmission dynamics of SARS-CoV-2 remain, and PPE recommendations may need to be modified in response to new evidence. [ABSTRACT FROM AUTHOR]

Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19) and for identifying asymptomatic carriage of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The number of available SARS-CoV-2 nucleic acid detection tests continues to increase as does the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) developed an evidence-based diagnostic guideline to assist clinicians, clinical laboratorians, patients, and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, we provide a conceptual framework for understanding molecular diagnostic test performance, discuss nuances of test result interpretation in a variety of practice settings, and highlight important unmet research needs related to COVID-19 diagnostic testing. IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. The panel agreed on 12 diagnostic recommendations. Access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention, and the public health response to COVID-19 infection. Information on the clinical performance of available tests continues to grow, but the quality of evidence of the current literature to support this updated molecular diagnostic guideline remains moderate to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is suggested for asymptomatic individuals with known or suspected contact with a COVID-19 case when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions. Evidence in support of rapid testing and testing of upper respiratory specimens other than nasopharyngeal swabs, which offer logistical advantages, is sufficient to warrant conditional recommendations in favor of these approaches. [ABSTRACT FROM AUTHOR]

Immunoassays designed to detect SARS-CoV-2 protein antigens (Ag) are commonly used to diagnose COVID-19. The most widely used tests are lateral flow assays that generate results in approximately 15 minutes for diagnosis at the point-of-care. Higher throughput, laboratory-based SARS-CoV-2 Ag assays have also been developed. The number of commercially available SARS-CoV-2 Ag detection tests has increased rapidly, as has the COVID-19 diagnostic literature. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the literature and develop best-practice guidance related to SARS-CoV-2 Ag testing. This guideline is an update to the third in a series of frequently updated COVID-19 diagnostic guidelines developed by the IDSA. IDSA's goal was to develop evidence-based recommendations or suggestions that assist clinicians, clinical laboratories, patients, public health authorities, administrators, and policymakers in decisions related to the optimal use of SARS-CoV-2 Ag tests in both medical and nonmedical settings. A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review identified and prioritized clinical questions related to the use of SARS-CoV-2 Ag tests. A review of relevant, peer-reviewed published literature was conducted through 1 April 2022. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. The panel made 10 diagnostic recommendations that address Ag testing in symptomatic and asymptomatic individuals and assess single versus repeat testing strategies. US Food and Drug Administration (FDA) SARS-CoV-2 Ag tests with Emergency Use Authorization (EUA) have high specificity and low to moderate sensitivity compared with nucleic acid amplification testing (NAAT). Ag test sensitivity is dependent on the presence or absence of symptoms and, in symptomatic patients, on timing of testing after symptom onset. In most cases, positive Ag results can be acted upon without confirmation. Results of point-of-care testing are comparable to those of laboratory-based testing, and observed or unobserved self-collection of specimens for testing yields similar results. Modeling suggests that repeat Ag testing increases sensitivity compared with testing once, but no empirical data were available to inform this question. Based on these observations, rapid RT-PCR or laboratory-based NAAT remain the testing methods of choice for diagnosing SARS-CoV-2 infection. However, when timely molecular testing is not readily available or is logistically infeasible, Ag testing helps identify individuals with SARS-CoV-2 infection. Data were insufficient to make a recommendation about the utility of Ag testing to guide release of patients with COVID-19 from isolation. The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate. [ABSTRACT FROM AUTHOR]

There are many pharmacologic therapies that are being used or considered for treatment of coronavirus disease 2019 (COVID-19), with rapidly changing efficacy and safety evidence from trials. The objective was to develop evidence-based, rapid, living guidelines intended to support patients, clinicians, and other healthcare professionals in their decisions about treatment and management of patients with COVID-19. In March 2020, the Infectious Diseases Society of America (IDSA) formed a multidisciplinary guideline panel of infectious disease clinicians, pharmacists, and methodologists with varied areas of expertise to regularly review the evidence and make recommendations about the treatment and management of persons with COVID-19. The process used a living guideline approach and followed a rapid recommendation development checklist. The panel prioritized questions and outcomes. A systematic review of the peer-reviewed and grey literature was conducted at regular intervals. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to assess the certainty of evidence and make recommendations. Based on the most recent search conducted on 31 May 2022, the IDSA guideline panel has made 32 recommendations for the treatment and management of the following groups/populations: pre- and postexposure prophylaxis, ambulatory with mild-to-moderate disease, and hospitalized with mild-to-moderate, severe but not critical, and critical disease. As these are living guidelines, the most recent recommendations can be found online at: https://idsociety.org/COVID19guidelines. At the inception of its work, the panel has expressed the overarching goal that patients be recruited into ongoing trials. Since then, many trials were conducted that provided much-needed evidence for COVID-19 therapies. There still remain many unanswered questions as the pandemic evolved, which we hope future trials can answer. [ABSTRACT FROM AUTHOR]

Background Since its emergence in late 2019, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to pose a risk to healthcare personnel (HCP) and patients in healthcare settings. Although all clinical interactions likely carry some risk of transmission, human actions, such as coughing, and care activities, such as aerosol-generating procedures, likely have a higher risk of transmission. The rapid emergence and global spread of SARS-CoV-2 continues to create significant challenges in healthcare facilities, particularly with shortages of the personal protective equipment (PPE) used by HCP. Evidence-based recommendations for what PPE to use in conventional, contingency, and crisis standards of care continue to be needed. Where evidence is lacking, the development of specific research questions can help direct funders and investigators. The purpose of the current study was to develop evidence-based rapid guidelines intended to support HCP in their decisions about infection prevention when caring for patients with suspected or known coronavirus disease 2019 (COVID-19). Methods The Infectious Diseases Society of America (IDSA) formed a multidisciplinary guideline panel including frontline clinicians, infectious disease specialists, experts in infection control, and guideline methodologists, with representation from the disciplines of public health, medical microbiology, pediatrics, critical care medicine and gastroenterology. The process followed a rapid recommendation checklist. The panel prioritized questions and outcomes. Then a systematic review of the peer-reviewed and gray literature was conducted. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence and make recommendations. Results The IDSA guideline panel agreed on 8 recommendations, including 2 updated recommendations and 1 new recommendation added since the first version of the guideline. Narrative summaries of other interventions undergoing evaluations are also included. Conclusions Using a combination of direct and indirect evidence, the panel was able to provide recommendations for 8 specific questions on the use of PPE by HCP providing care for patients with suspected or known COVID-19. Where evidence was lacking, attempts were made to provide potential avenues for investigation. There remain significant gaps in the understanding of the transmission dynamics of SARS-CoV-2, and PPE recommendations may need to be modified in response to new evidence. These recommendations should serve as a minimum for PPE use in healthcare facilities and do not preclude decisions based on local risk assessments or requirements of local health jurisdictions or other regulatory bodies. [ABSTRACT FROM AUTHOR]

Immunoassays designed to detect SARS-CoV-2 protein antigens are now commercially available. The most widely used tests are rapid lateral flow assays that generate results in ~15 minutes for diagnosis at the point-of-care. Higher throughput, laboratory-based SARS-CoV-2 antigen (Ag) assays have also been developed. The overall accuracy of SARS-CoV-2 Ag tests, however, is not well defined. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the literature and develop best-practice guidance related to SARS-CoV-2 Ag testing. This guideline is the third in a series of rapid, frequently updated COVID-19 diagnostic guidelines developed by IDSA. IDSA's goal was to develop evidence-based recommendations or suggestions that assist clinicians, clinical laboratories, patients, public health authorities, administrators, and policymakers in decisions related to the optimal use of SARS-CoV-2 Ag tests in both medical and nonmedical settings. A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review identified and prioritized clinical questions related to the use of SARS-CoV-2 Ag tests. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. The panel agreed on 5 diagnostic recommendations. These recommendations address Ag testing in symptomatic and asymptomatic individuals as well as assess single versus repeat testing strategies. Data on the clinical performance of US Food and Drug Administration SARS-CoV-2 Ag tests with Emergency Use Authorization are mostly limited to single, one-time testing versus standard nucleic acid amplification testing (NAAT) as the reference standard. Rapid Ag tests have high specificity and low to modest sensitivity compared with reference NAAT methods. Antigen test sensitivity is heavily dependent on viral load, with differences observed between symptomatic compared with asymptomatic individuals and the time of testing post-onset of symptoms. Based on these observations, rapid reverse transcriptase–polymerase chain reaction (RT-PCR) or laboratory-based NAAT remain the diagnostic methods of choice for diagnosing SARS-CoV-2 infection. However, when molecular testing is not readily available or is logistically infeasible, Ag testing can help identify some individuals with SARS-CoV-2 infection. The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate. [ABSTRACT FROM AUTHOR]

Background Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19). Direct detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in respiratory tract specimens informs patient, healthcare institution and public health level decision-making. The numbers of available SARS-CoV-2 nucleic acid detection tests are rapidly increasing, as is the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) recognized a significant need for frequently updated systematic reviews of the literature to inform evidence-based best practice guidance. Objective The IDSA's goal was to develop an evidence-based diagnostic guideline to assist clinicians, clinical laboratorians, patients and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, we provide a conceptual framework for understanding molecular diagnostic test performance, discuss the nuance of test result interpretation in a variety of practice settings and highlight important unmet research needs in the COVID-19 diagnostic testing space. Methods IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. Results The panel agreed on 17 diagnostic recommendations. Conclusions Universal access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention and the public response to the COVID-19 pandemic. Information on the clinical performance of available tests is rapidly emerging, but the quality of evidence of the current literature is considered moderate to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is recommended for asymptomatic individuals with known or suspected contact with a COVID-19 case. Testing asymptomatic individuals without known exposure is suggested when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions, dictate eligibility for surgery, or inform solid organ or hematopoietic stem cell transplantation timing. Ultimately, prioritization of testing will depend on institutional-specific resources and the needs of different patient populations. [ABSTRACT FROM AUTHOR]

This systematic review of cost-effectiveness analyses of newer antidiabetes medications for type 2 diabetes was done to inform the ACP clinical guideline on newer pharmacologic treatments in adults with type 2 diabetes. It evaluates the nonindustry-funded cost-effectiveness analyses that estimate the cost per quality-adjusted life-years gained for SGLT2 inhibitors, GLP1 agonists, DPP4 inhibitors, and long-acting insulins as monotherapy or combination therapy in treating adults with type 2 diabetes mellitus. Background: In the United States, costs of antidiabetes medications exceed $327 billion. Purpose: To systematically review cost-effectiveness analyses (CEAs) of newer antidiabetes medications for type 2 diabetes. Data Sources: Bibliographic databases from 1 January 2010 through 13 July 2023, limited to English. Study Selection: Nonindustry-funded CEAs, done from a U.S. perspective that estimated cost per quality-adjusted life-year (QALY) gained for newer antidiabetic medications. Two reviewers screened the literature; disagreements were resolved with a third reviewer. Data Extraction: Cost-effectiveness analyses were reviewed for treatment comparisons, model inputs, and outcomes. Risk of bias (RoB) of the CEAs was assessed using Drummond criteria and certainty of evidence (CoE) was assessed using GRADE (Grading of Recommendations Assessment, Development, and Evaluations). Certainty of evidence was determined using cost per QALY thresholds predetermined by the American College of Physicians Clinical Guidelines Committee; low (>$150 000), intermediate ($50 to $150 000), or high (<$50 000) value per QALY compared with the alternative. Data Synthesis: Nine CEAs were eligible (2 low, 1 high, and 6 some concerns RoB), evaluating glucagon-like peptide-1 agonists (GLP1a), dipeptidyl peptidase-4 inhibitors (DPP4i), sodium–glucose cotransporter-2 inhibitors (SGLT2i), glucose-dependent insulinotropic peptide agonist (GIP/GLP1a), and insulin. Comparators were metformin, sulfonylureas, neutral protamine Hagedorn (NPH) insulin, and others. Compared with metformin, GLP1a and SGLT2i are low value as first-line therapy (high CoE) but may be of intermediate value when added to metformin or background therapy compared with adding nothing (low CoE). Insulin analogues may be similarly effective but more expensive than NPH insulin (low CoE). The GIP/GLP1a value is uncertain (insufficient CoE). Limitations: Cost-effectiveness analyses varied in methodological approach, assumptions, and drug comparisons. Risk of bias and GRADE method for CEAs are not well established. Conclusion: Glucagon-like peptide-1 agonists and SGLT2i are of low value as first-line therapy but may be of intermediate value when added to metformin or other background therapy compared with adding nothing. Other drugs and comparisons are of low or uncertain value. Results are sensitive to drug effectiveness and cost assumptions. Primary Funding Source: American College of Physicians. (PROSPERO: CRD42022382315) [ABSTRACT FROM AUTHOR]

This systematic review on the effect of newer diabetes medications on mortality, cardiovascular outcomes, and renal outcomes was conducted to inform the ACP clinical guideline on newer pharmacologic treatments in adults with type 2 diabetes mellitus. It evaluates the effectiveness, comparative effectiveness, and harms of sodium–glucose cotransporter-2 (SGLT2) inhibitors, glucagon-like peptide-1 (GLP1) agonists, dipeptidyl peptidase-4 (DPP4) inhibitors, and long-acting insulins as monotherapy or combination therapy in treating adults with type 2 diabetes mellitus. Background: Newer diabetes medications may have beneficial effects on mortality, cardiovascular outcomes, and renal outcomes. Purpose: To evaluate the effectiveness, comparative effectiveness, and harms of sodium–glucose cotransporter-2 (SGLT2) inhibitors, glucagon-like peptide-1 (GLP1) agonists, dipeptidyl peptidase-4 (DPP4) inhibitors, and long-acting insulins as monotherapy or combination therapy in adults with type 2 diabetes mellitus (T2DM). Data Sources: MEDLINE and EMBASE for randomized controlled trials (RCTs) published from 2010 through January 2023. Study Selection: RCTs lasting at least 52 weeks that included at least 500 adults with T2DM receiving eligible medications and reported any outcomes of interest. Data Extraction: Data were abstracted by 1 reviewer and verified by a second. Independent, dual assessments of risk of bias and certainty of evidence (CoE) were done. Data Synthesis: A total of 130 publications from 84 RCTs were identified. CoE was appraised using GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria for direct, indirect, and network meta-analysis (NMA); the highest CoE was reported. Compared with usual care, SGLT2 inhibitors and GLP1 agonists reduce all-cause mortality (high CoE) and major adverse cardiovascular events (MACE) (moderate to high CoE), SGLT2 inhibitors reduce progression of chronic kidney disease (CKD) and heart failure hospitalizations and GLP1 agonists reduce stroke (high CoE), and SGLT2 inhibitors reduce serious adverse events and severe hypoglycemia (high CoE). The threshold for minimally important differences, which was predefined with the American College of Physicians Clinical Guidelines Committee, was not met for these outcomes. Compared with usual care, insulin, tirzepatide, and DPP4 inhibitors do not reduce all-cause mortality (low to high CoE). Compared with insulin, SGLT2 inhibitors and GLP1 agonists reduce all-cause mortality (low to moderate CoE). Compared with DPP4 inhibitors, GLP1 agonists reduce all-cause mortality (moderate CoE). Compared with DPP4 inhibitors and sulfonylurea (SU), SGLT2 inhibitors reduce MACE (moderate to high CoE). Compared with SU and insulin, SGLT2 inhibitors and GLP1 agonists reduce severe hypoglycemia (low to high CoE). Limitations: Infrequent direct comparisons between drugs of interest; sparse data for NMA on most outcomes; possible incoherence due to differences in baseline patient characteristics and usual care; insufficient data on predefined subgroups, including demographic subgroups, patients with prior cardiovascular disease, and treatment-naive persons. Conclusion: In adults with T2DM, SGLT2 inhibitors and GLP1 agonists (but not DPP4 inhibitors, insulin, or tirzepatide) reduce all-cause mortality and MACE compared with usual care. SGLT2 inhibitors reduce CKD progression and heart failure hospitalization and GLP1 agonists reduce stroke compared with usual care. Serious adverse events and severe hypoglycemia are less frequent with SGLT2 inhibitors and GLP1 agonists than with insulin or SU. Primary Funding Source: American College of Physicians. (PROSPERO: CRD42022322129) [ABSTRACT FROM AUTHOR]

INTRODUCTION: Whether dye spray chromoendoscopy (DCE) adds value in surveillance colonoscopy with high-definition (HD) scopes remains controversial. This updated meta-analysis compares dysplasia detection using DCE and high-definition white light endoscopy (HD-WLE) in patients with inflammatory bowel disease (IBD) undergoing surveillance colonoscopy. METHODS: A comprehensive search was performed for randomized controlled trials (RCT) comparing HD-WLE and DCE in patients with IBD. The primary outcome was to compare the proportion of patients with at least 1 dysplastic lesion detected by DCE vs HD-WLE. Odds ratios (OR) and95%confidence intervals (CI) were pooled using the random-effects model, with I² > 60% indicating substantial heterogeneity. The Grading of Recommendations, Assessment, Development, and Evaluation approach was used to assess the certainty of evidence (CoE). RESULTS: Six RCT involving 978 patients were analyzed (DCE5479 vs HD-WLE5499 patients). DCE detected significantlymore patients with dysplasia thanHD-WLE (18.8%vs9.4%), OR1.94 (95%CI1.21-3.11, I²=28%, P50.006, highCoE). This remained significant after excluding2 RCTpublished as abstracts. A sensitivity analysis excluding a noninferiority RCT with a single experienced operator eliminated the results' heterogeneity, OR 2.46 (95%CI 1.56-3.90, I²=0%). Although high-grade dysplasia detection was numerically higher in the DCE group (2.8% vs 1.1%), the difference was statistically insignificant, OR 2.21 (95% CI 0.64-7.62, I² = 0%, low CoE). DISCUSSION: Our updated meta-analysis supports DCE as a superior strategy in overall dysplasia detection in IBD, even with HD scopes. When expertise is available, DCE should be considered for surveillance colonoscopy in patients with high-risk IBD, with the acknowledgment that virtual chromoendoscopy shows equivalence in recent studies. Further multicenter trials with multiple endoscopists with varying expertise levels and longer-term outcome data showing a reduction in cancer or cancer-related death are needed. [ABSTRACT FROM AUTHOR]

The article offers information on how to provide a sound prognosis and recommendation for sunitinib treatment in patient with metastatic renal cell carcinoma (RCC) who have undergone right radical nephrectomy. It suggests the retrieval of relevant guidelines for clinical recommendations from the National Institute for Clinical Excellence (NICE). Moreover, it discusses the importance of early stopping of the randomized controlled trials (RCTs) for benefit in clinical trials involving sunitinib.

Since the US Food and Drug Administration banned the use of dietary supplements containing ephedra in February 2004, numerous "ephedra-free" weight-loss products have appeared on the market. Many of these supplements contain compounds such as bitter orange that are similar in structure and action to ephedra. We describe a patient in whom ischemic colitis developed 1 week after initiation of a bitter orange-containing weight-loss supplement. The patient had no other predisposing factors, and discontinuation of the supplement led to immediate improvement and ultimate resolution of her symptoms. Both consumers and health care professionals should be aware of the potential harm that bitter orange-containing dietary supplements can cause and report such adverse events to the US Food and Drug Administration. [ABSTRACT FROM AUTHOR]

Examines whether computer simulation can accelerate the development of procedural competence in gastroenterology. Limitations of hardware and computer programming techniques; Need to present images at a rate of around 30 frames per second; Use of simulators to teach techniques for thermal hemostasis of bleeding vessels.

Background: Assessing certainty of evidence is a key element of any systematic review. The aim of this meta-epidemiology study was to understand the frequency and ways with which certainty of evidence is assessed in contemporary systematic reviews published in high-impact sports science journals. Methods: We searched PubMed and relevant journal web sites from 1 August 2016 to 11 October 2022 for systematic reviews published in the top-ten highest-impact journals within the 2020 Journal Citation Report for the Sports Sciences category. Pairs of independent reviewers screened items using a priori established criteria. Results: Of 1250 eligible documents, 258 (20.6%) assessed the certainty of evidence, defined as using two or more distinct domains to provide an overall rating of the trustworthiness of findings across studies. Nine methods were cited for assessing certainty, with the most common being the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach (61.6%). The proportion of systematic reviews assessing certainty of evidence appeared to increase over the 6-year timeframe analyzed. Across all reviews analyzed, a large majority addressed the domains of risk of bias, imprecision, and inconsistency of the results. Other certainty domains including indirectness/applicability were less commonly assessed. Discussion: Only one in five recent contemporary systematic reviews in the field of exercise and sports science assessed certainty of evidence. Organizational and institutional education on methods for assessing evidence may help further increase uptake of these methods and improve both the quality and clinical impact of systematic reviews in the field. [ABSTRACT FROM AUTHOR]

The article reports on a study investigating the relative effectiveness of polyethylene glycol (PEG) and lactulose for treatment of chronic constipation and fecal impaction in children and adults. In this randomized controlled trial, PEG were compared with lactulose in children or adults with chronic constipation or fecal impaction. It was found in the study that polyethylene glycol is more effective than lactulose for treatment of chronic constipation.

The article offers the author's views on a research study which studied the advantages of enteral nutrition (EN) and total parenteral nutrition (TPN) in patients with acute pancreatitis. The research concluded that EN reduces mortality, multiple organ failure, systemic infections and operative interventions more than TPN in patients with acute pancreatitis. The author opines that EN is safer and more effective than TPN for providing nutrition to patients with acute pancreatitis.

The article offers information on a research regarding mortality risks in patients with acute pancreatitis provided with enteral or parenteral nutrition. Studies selected compared standard enteral or parenteral nutrition with no supplementary nutrition or enteral nutrition with parenteral nutrition in patients with acute pancreatitis. It was observed that enteral or parenteral nutrition reduces risk for mortality in case of acute pancreatitis.

INTRODUCTION: Chronic idiopathic constipation (CIC) is a common disorder associated with significant impairment in quality of life. This clinical practice guideline, jointly developed by the American Gastroenterological Association and the American College of Gastroenterology, aims to inform clinicians and patients by providing evidence-based practice recommendations for the pharmacological treatment of CIC in adults. METHODS: The American Gastroenterological Association and the American College of Gastroenterology formed a multidisciplinary guideline panel that conducted systematic reviews of the following agents: fiber, osmotic laxatives (polyethylene glycol,magnesium oxide,lactulose) stimulantlaxatives (bisacodyl, sodium picosulfate, senna) secretagogues (lubiprostone, linaclotide, plecanatide) and serotonin type 4 agonist (prucalopride). The panel prioritized clinical questions and outcomes and used theGrading ofRecommendations Assessment, Development, and Evaluation framework to assess the certainty of evidence for each intervention. The Evidence to Decision framework was used to develop clinical recommendations based on the balance between the desirable and undesirable effects, patient values, costs, and health equity considerations. RESULTS: The panel agreed on 10 recommendations for the pharmacological management of CIC in adults. Based on available evidence, the panel made strong recommendations for the use of polyethylene glycol, sodium picosulfate, linaclotide, plecanatide, and prucalopride for CIC in adults. Conditional recommendations were made for the use of fiber, lactulose, senna, magnesium oxide, and lubiprostone. DISCUSSION: This document provides a comprehensive outline of the various over-the-counter and prescription pharmacological agents available for the treatment of CIC. The guidelines are meant to provide a framework for approaching the management of CIC; clinical providers should engage in shared decision making based on patient preferences as well as medication cost and availability. Limitations and gaps in the evidence are highlighted to help guide future research opportunities and enhance the care of patients with chronic constipation. [ABSTRACT FROM AUTHOR]

The start of the COVID-19 pandemic presented a situation in which there was an urgent need for decision-making that relates to diagnosis, but the evidence was lacking, of low certainty or constantly changing. Rapid and living guideline development methods were needed and had to be applied to rigorous guideline approaches, such as the Grading of Recommendations Assessment, Development, and Evaluation approach. To describe the process of developing rapid diagnosis guidelines when there is limited and imperfect available data at the time of crisis. Case example from four Infectious Disease Society of America COVID-19 diagnostic guidelines. As the world was experiencing panic with COVID-19, there were serious doubts about the feasibility of following a rigorous process for guideline development when timeliness was of extreme value. The Infectious Disease Society of America guideline panels supported by several methodologists strongly believed that at times of crisis, it is more important than ever to follow a rigorous process. The panel adopted a rapid and living systematic review methodology and applied the Grading of Recommendations Assessment, Development and Evaluation approach to four diagnosis guidelines despite the challenges of scarce and dynamic evidence. We describe the methodological details of the rapid and living approach (data extraction, meta-analysis, Evidence to Decision framework, and recommendation development), the challenge of resources, the challenge of scarce evidence, the challenge of rapidly changing evidence, as well as 'wins' from the Infectious Disease Society of America experience. Mitigation of pandemics relies on rapid and accurate diagnosis, which is challenged by many knowledge gaps. This necessitates emerging evidence is rapidly incorporated in a living fashion with several decisional and contextual factors to ensure the best public health strategies and care for patients. This process must be systematic and transparent for developing trustworthy guidelines and should be supported by all stakeholders, including researchers, editors, publishers, professional societies, and policymakers. [ABSTRACT FROM AUTHOR]

Background: In adults with diabetes, diabetic foot ulcer (DFU) and amputation are common and associated with significant morbidity and mortality. Purpose: Identify tools predicting risk of DFU or amputation that are prognostically accurate and clinically feasible. Methods: We searched for systematic reviews (SRs) of tools predicting DFU or amputation published in multiple databases from initiation to January, 2023. We assessed risk of bias (ROB) and provided a narrative review of reviews describing performance characteristics (calibration and discrimination) of prognostically accurate tools. For such tools, we additionally reviewed original studies to ascertain clinical applicability and usability (variables included, score calculation, and risk categorization). Results: We identified 3 eligible SRs predicting DFU or amputation risk. Two recent SRs (2020 and 2021) were rated as moderate and low ROB respectively. Four risk prediction models – Boyko, Martins-Mendes (simplified), Martins-Mendes (original), and PODUS 2020 had good prognostic accuracy for predicting DFU or amputation over time horizons ranging from 1- to 5-years. PODUS 2020 predicts absolute average risk (e.g., 6% risk of DFU at 2 years) and consists of 3-binary variables with a simple, summative scoring (0–4) making it feasible for clinic use. The other 3 models categorize risk subjectively (e.g., high-risk for DFU at 3 years), include 2–7 variables, and require a calculation device. No data exist to inform rescreening intervals. Furthermore, the effectiveness of targeted interventions in decreasing incidence of DFU or amputation in response to prediction scores is unknown. Conclusions: In this review of reviews, we identified 4 prognostically accurate models that predict DFU or amputation in persons with diabetes. The PODUS 2020 model, predicting absolute average DFU risk at 2 years, has the most favorable prognostic accuracy and is clinically feasible. Rescreening intervals and effectiveness of intervention based on prediction score are uncertain. [ABSTRACT FROM AUTHOR]

GRADE requires guideline developers to make an overall rating of confidence in estimates of effect (quality of evidencedhigh, moderate, low, or very low) for each important or critical outcome. GRADE suggests, for each outcome, the initial separate consideration of five domains of reasons for rating down the confidence in effect estimates, thereby allowing systematic review authors and guideline developers to arrive at an outcome-specific rating of confidence. Although this rating system represents discrete steps on an ordinal scale, it is helpful to view confidence in estimates as a continuum, and the final rating of confidence may differ from that suggested by separate consideration of each domain. An overall rating of confidence in estimates of effect is only relevant in settings when recommendations are being made. In general, it is based on the critical outcome that provides the lowest confidence. [ABSTRACT FROM AUTHOR]

Abstract: The most common reason for rating up the quality of evidence is a large effect. GRADE suggests considering rating up quality of evidence one level when methodologically rigorous observational studies show at least a two-fold reduction or increase in risk, and rating up two levels for at least a five-fold reduction or increase in risk. Systematic review authors and guideline developers may also consider rating up quality of evidence when a dose–response gradient is present, and when all plausible confounders or biases would decrease an apparent treatment effect, or would create a spurious effect when results suggest no effect. Other considerations include the rapidity of the response, the underlying trajectory of the condition, and indirect evidence. [Copyright &y& Elsevier]

OBJECTIVE To determine to what extent urologists with no specific training agree upon level of evidence (LoE) ratings of studies published in the urological literature, as LoE are commonly referenced as a measure of evidence quality. MATERIALS AND METHODS In all, 86 clinical research studies published in four major urology journals were reviewed. Each article was independently reviewed by eight reviewers using a standardized data abstraction form. Articles were assessed for type of study (therapy, prognosis, diagnosis or economic) and LoE (I, II, III or IV). Reviewers received only written instructions and no formal training in the application of this classification system. RESULTS Of the 86 articles, 69% related to therapy, 16% to prognosis, and 15% to diagnosis. Eight studies (9%) provided Level I evidence, 18 studies (21%) Level II, 14 studies (16%) Level III and 46 studies (54%) Level IV evidence. The intraclass correlation coefficient (95% confidence interval) based on all reviewers (eight reviewers) was 0.67 (0.59–0.74; P= 0.001) for the type of study and 0.55 (0.48–0.64; P= 0.001) for the LoE. In an analysis limited to a subset of studies in which all reviewers agreed upon the type of study question ( n= 40) the intraclass correlation coefficient was 0.79 (0.70–0.86; P= 0.001). CONCLUSION In the present study there was a low interobserver agreement for LoE ratings by urologists with no specific training. These findings suggest caution in the interpretation of LoE ratings and emphasize the importance of specific training for individuals that are charged with quality of evidence determinations. [ABSTRACT FROM AUTHOR]

Purpose: Selective serotonin re-uptake inhibitors (SSRIs) are frequently used to treat premature ejaculation (PE) in men. We performed a Cochrane review to assess the efficacy of SSRI treatment for PE. Materials and Methods: We extensively searched a range of databases up to May 2020 and only included randomized controlled trials. Results: A total of 31 studies with 8,254 men were included in this analysis. We found that SSRI treatment probably improves self-perceived PE symptoms (defined as a rating of ‘better’ or ‘much better’; risk ratio [RR], 1.92; 95% confidence interval [CI], 1.66–2.23; moderate-certainty evidence) and satisfaction with intercourse (defined as a rating of ‘good’ or ‘very good’; RR, 1.63; 95% CI, 1.42–1.87; moderate-certainty evidence) compared to placebo. Furthermore, SSRI treatment likely improve participants’ self-perceived control over ejaculation (defined as rating of ‘good’ or ‘very good’; RR, 2.29; 95% CI, 1.72–3.05; moderate-certainty evidence) and probably lessens distress (defined as rating of ‘a little bit’ or ‘not at all’) about PE (RR, 1.54; 95% CI, 1.26–1.88; moderate-certainty evidence). SSRI treatment may increase IELT compared to placebo (mean difference, 3.09 minutes higher; 95% CI, 1.94 higher to 4.25 higher; low-certainty evidence). However, SSRIs may increase treatment cessations due to adverse events compared to placebo (RR, 3.80; 95% CI, 2.61–5.51; low-certainty evidence). Conclusions: SSRI treatment for PE appears to substantially improve a number of outcomes of direct patient importance such as symptom improvement, satisfaction with intercourse and perceived control over ejaculation when compared to placebo. [ABSTRACT FROM AUTHOR]

Background: In 2021, the United States Preventive Services Task Force updated their recommendation, stating that individuals ages 45-49 should initiate screening for colorectal cancer. Since several screening strategies are recommended, making a shared decision involves including an individual's preferences. Few studies have included individuals under age 50. In this study, we use a multicriteria decision analysis technique called the Analytic Hierarchy Process to explore preferences for screening strategies and evaluate whether preferences vary by age. Methods: Participants evaluated a hierarchy with 3 decision alternatives (colonoscopy, fecal immunochemical test, and computed tomography colonography), 3 criteria (test effectiveness, the screening plan, and features of the test) and 7 sub-criteria. We used the linear fit method to calculate consistency ratios and the eigenvector method for group preferences. We conducted sensitivity analysis to assess whether results are robust to change and tested differences in preferences by participant variables using chi-square and analysis of variance. Results: Of the 579 individuals surveyed, 556 (96%) provided complete responses to the AHP portion of the survey. Of these, 247 participants gave responses consistent enough (CR < 0.18) to be included in the final analysis. Participants that were either white or have lower health literacy were more likely to be excluded due to inconsistency. Colonoscopy was the preferred strategy in those < 50 and fecal immunochemical test was preferred by those over age 50 (p = 0.002). These results were consistent when we restricted analysis to individuals ages 45-55 (p = 0.011). Participants rated test effectiveness as the most important criteria for making their decision (weight = 0.555). Sensitivity analysis showed our results were robust to shifts in criteria and sub-criteria weights. Conclusions: We reveal potential differences in preferences for screening strategies by age that could influence the adoption of screening programs to include individuals under age 50. Researchers and practitioners should consider at-home interventions using the Analytic Hierarchy Process to assist with the formulation of preferences that are key to shared decision-making. The costs associated with different preferences for screening strategies should be explored further if limited resources must be allocated to screen individuals ages 45-49. [ABSTRACT FROM AUTHOR]

Background: In 2021, the United States Preventive Services Task Force updated their recommendation, stating that individuals ages 45-49 should initiate screening for colorectal cancer. Since several screening strategies are recommended, making a shared decision involves including an individual's preferences. Few studies have included individuals under age 50. In this study, we use a multicriteria decision analysis technique called the Analytic Hierarchy Process to explore preferences for screening strategies and evaluate whether preferences vary by age. Methods: Participants evaluated a hierarchy with 3 decision alternatives (colonoscopy, fecal immunochemical test, and computed tomography colonography), 3 criteria (test effectiveness, the screening plan, and features of the test) and 7 sub-criteria. We used the linear fit method to calculate consistency ratios and the eigenvector method for group preferences. We conducted sensitivity analysis to assess whether results are robust to change and tested differences in preferences by participant variables using chi-square and analysis of variance. Results: Of the 579 individuals surveyed, 556 (96%) provided complete responses to the AHP portion of the survey. Of these, 247 participants gave responses consistent enough (CR < 0.18) to be included in the final analysis. Participants that were either white or have lower health literacy were more likely to be excluded due to inconsistency. Colonoscopy was the preferred strategy in those < 50 and fecal immunochemical test was preferred by those over age 50 (p = 0.002). These results were consistent when we restricted analysis to individuals ages 45-55 (p = 0.011). Participants rated test effectiveness as the most important criteria for making their decision (weight = 0.555). Sensitivity analysis showed our results were robust to shifts in criteria and sub-criteria weights. Conclusions: We reveal potential differences in preferences for screening strategies by age that could influence the adoption of screening programs to include individuals under age 50. Researchers and practitioners should consider at-home interventions using the Analytic Hierarchy Process to assist with the formulation of preferences that are key to shared decision-making. The costs associated with different preferences for screening strategies should be explored further if limited resources must be allocated to screen individuals ages 45-49. [ABSTRACT FROM AUTHOR]

A correction to the article "The quality of physical activity guidelines, but not the specificity of their recommendations, has improved over time: a systematic review and critical appraisal" that was published in a 2021 issue is presented.

While numerous guidelines for the prescription of physical activity are released each year, the quality and practicability of these guidelines is unknown. We assessed the quality of 95 guidance documents published since 2000 that included recommendations about physical activity for the promotion of general health and prevention of cardiometabolic disease. We used 3 tools: Appraisal of Guidelines for Research and Evaluation (AGREE II), the National Academy of Medicine's (NAM) Standards for Trustworthy Clinical Practice Guidelines, and the Frequency, Intensity, Time, and Type (FITT) score. Average AGREE II domain scores ranged from 38%−84%, and the portion of criteria fulfilled per NAM domain ranged from 7%–39%. The average FITT score for all recommendations was 2.48 out of 4. While guidelines improved according to both AGREE II and the NAM standards over time, their practicability as assessed by FITT score did not improve. Guidelines produced by governmental agencies or other nonprofit organizations, using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach, or fulfilling a higher number of NAM criteria tended to be of higher quality. Organizations producing physical activity guidelines can improve their quality by establishing and reporting processes for public representation, external review, and conflict of interest (COI) management. Future recommendations about physical activity should be more specific and include strategies to improve implementation. Registration no.: PROSPERO CRD42019126364. Novelty: Most physical activity recommendations are not sufficiently specific to be practically implemented. The overall quality of guidelines has improved over time, but the specificity of recommendations has not. Improved public representation, external review, and COI disclosure and management processes would improve guideline quality. [ABSTRACT FROM AUTHOR]

Patients with Barrett's esophagus (BE) are at increased risk of esophageal adenocarcinoma (EAC). The risk is largely based on the degree of dysplasia. Dysplasia cannot always be differentiated from inflammatory changes, and therefore may be classified as indefinite for dysplasia (IND). The risk of progressive dysplasia in patients with IND is unclear. Our aim is to characterize the risk of progression in US veterans with BE-IND. We performed a single-center retrospective cohort study of patients with BE-IND between 2006 and 2016. All IND was diagnosed by consensus conference with an expert gastrointestinal (GI) pathologist or review by an expert GI pathologist and persistence was defined as IND present on subsequent endoscopic biopsy. The primary outcome was the incidence rate of high-grade dysplasia (HGD)/EAC. Secondary outcomes included any progression including incident low-grade dysplasia (LGD), any prevalent dysplasia and risk factors for dysplastic progression, namely persistent IND. Risk factors for progression were assessed using univariate and multivariate analysis with logistic regression. Among 107 patients with BE-IND, there were no incident cases of HGD/EAC. Twenty patients (18.7%) developed incident LGD during a median follow-up of 2.39 years (interquartile range, 1.13–5.17). The annual rate of progression to LGD was 5.95 per 100 patient-years (95% CI, 3.73–9.02). Prevalent dysplasia was common (9.3%). Eight patients had prevalent LGD, one patient had prevalent HGD and one patient had prevalent EAC. Twenty-eight patients (30.1%) were found to have persistent IND. Among those with persistent IND, 10 (36%) patients progressed to LGD (none to HGD/EAC). The progression rate to LGD for patients with persistent IND was 7.86 (95% CI, 3.99–14.02) cases per 100 patient-years versus 4.78 (95% CI, 2.48–8.52) for nonpersistent IND (P  = 0.036). The odds ratio for progression to LGD in persistent IND was 3.06 (95% CI, 1.08–8.64). In multivariate analysis adjusting for age, smoking history, presence of hiatal hernia and BMI > 30, persistent IND remained significant (OR 3.23; 95% CI, 1.04–9.98). Regression to nondysplastic BE was very common. Seventy-one (61%) patients developed complete and sustained regression of all dysplastic changes at last follow-up. Persistent IND, present in one-third of patients with IND, is an independent risk factor for progression to LGD. Although no patients in this cohort developed HGD/EAC, prevalent dysplasia was common (9.3%). Taken together, patients with IND should receive close surveillance for both prevalent and incident dysplasia especially if IND is persistent. [ABSTRACT FROM AUTHOR]

The article presents the authors' views on the use of GRADE and the Canadian Urological Association's (CUA) commitment to the future use of this approach to rating the quality of evidence in its guidelines. CUA's current guideline regarding the diagnosis and treatment of antenatally detected hydronephrosis is also mentioned.