Grading Of Recommendations Assessment, Development, And Evaluation Methodology Research Articles

Clinical guideline on reversal of direct oral anticoagulants in patients with life threatening bleeding.

Anticoagulation is essential for the treatment and prevention of thromboembolic events. Current guidelines recommend direct oral anticoagulants (DOACs) over vitamin K antagonists in DOAC-eligible patients. The major complication of anticoagulation is serious or life-threatening haemorrhage, which may necessitate prompt haemostatic intervention. Reversal of DOACs may also be required for patients in need of urgent invasive procedures. This guideline from the European Society of Anaesthesiology and Intensive Care (ESAIC) aims to provide evidence-based recommendations and suggestions on how to manage patients on DOACs undergoing urgent or emergency procedures including the treatment of DOAC-induced bleeding. A systematic literature search was performed, examining four drug comparators (dabigatran, rivaroxaban, apixaban, edoxaban) and clinical scenarios ranging from planned to emergency surgery with the outcomes of mortality, haematoma growth and thromboembolic complications. The GRADE (Grading of Recommendations, Assessment, Development and Evaluation) methodology was used to assess the methodological quality of the included studies. Consensus on the wording of the recommendations was achieved by a Delphi process. So far, no results from prospective randomised trials comparing two active comparators (e.g. a direct reversal agent and an unspecific haemostatic agent such as prothrombin complex concentrate: PCC) have been published yet and the majority of publications were uncontrolled and observational studies. Thus, the certainty of evidence was assessed to be either low or very low (GRADE C). Thirty-five recommendations and clinical practice statements were developed. During the Delphi process, strong consensus (>90% agreement) was achieved in 97.1% of recommendations and consensus (75 to 90% agreement) in 2.9%. DOAC-specific coagulation monitoring may help in patients at risk for elevated DOAC levels, whereas global coagulation tests are not recommended to exclude clinically relevant DOAC levels. In urgent clinical situations, haemostatic treatment using either the direct reversal or nonspecific haemostatic agents should be started without waiting for DOAC level monitoring. DOAC levels above 50 ng ml-1 may be considered clinically relevant necessitating haemostatic treatment before urgent or emergency procedures. Before cardiac surgery under activated factor Xa (FXa) inhibitors, the use of andexanet alfa is not recommended because of inhibition of unfractionated heparin, which is needed for extracorporeal circulation. In the situation of DOAC overdose without bleeding, no haemostatic intervention is suggested, instead measures to eliminate the DOACs should be taken. Due to the lack of published results from comparative prospective, randomised studies, the superiority of reversal treatment strategy vs. a nonspecific haemostatic treatment is unclear for most urgent and emergency procedures and bleeding. Due to the paucity of clinical data, no recommendations for the use of recombinant activated factor VII as a nonspecific haemostatic agent can be given. In the clinical scenarios of DOAC intake before urgent procedures and DOAC-induced bleeding, practitioners should evaluate the risk of bleeding of the procedure and the severity of the DOAC-induced bleeding before initiating treatment. Optimal reversal strategy remains to be determined in future trials for most clinical settings.

European Academy of Neurology (EAN) guideline on the management of amyotrophic lateral sclerosis in collaboration with European Reference Network for Neuromuscular Diseases (ERN EURO-NMD).

This update of the guideline on the management of amyotrophic lateral sclerosis (ALS) was commissioned by the European Academy of Neurology (EAN) and prepared in collaboration with the European Reference Network for Neuromuscular Diseases (ERN EURO-NMD) and the support of the European Network for the Cure ALS (ENCALS) and the European Organization for Professionals and Patients with ALS (EUpALS). Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was used to assess the effectiveness of interventions for ALS. Two systematic reviewers from Cochrane Response supported the guideline panel. The working group identified a total of 26 research questions, performed systematic reviews, assessed the quality of the available evidence, and made specific recommendations. Expert consensus statements were provided where insufficient evidence was available. A guideline mapping effort revealed only one other ALS guideline that used GRADE methodology (a National Institute for Health and Care Excellence [NICE] guideline). The available evidence was scarce for many research questions. Of the 26 research questions evaluated, the NICE recommendations could be adapted for 8 questions. Other recommendations required updates of existing systematic reviews or de novo reviews. Recommendations were made on currently available disease-modifying treatments, multidisciplinary care, nutritional and respiratory support, communication aids, psychological support, treatments for common ALS symptoms (e.g., muscle cramps, spasticity, pseudobulbar affect, thick mucus, sialorrhea, pain), and end-of-life management. This update of the guideline using GRADE methodology provides a framework for the management of ALS. The treatment landscape is changing rapidly, and further updates will be prepared when additional evidence becomes available.

Evidence-Based Guideline for the Treatment of Smoking Cessation Provided by the National Health Insurance Service in Korea.

Although major countries, such as South Korea, have developed and disseminated national smoking cessation guidelines, these efforts have been limited to developing individual societies or specialized institution-based recommendations. Therefore, evidence-based clinical guidelines are essential for developing smoking cessation interventions and promoting effective smoking cessation treatments. This guideline targets frontline clinical practitioners involved in a smoking cessation treatment support program implemented in 2015 with the support of the National Health Insurance Service. The Guideline Development Group of 10 multidisciplinary smoking cessation experts employed the Grading of Recommendations Assessment, Development, and Evaluation (GRADE)-ADOLOPMENT approach to review recent domestic and international research and guidelines and to determine evidence levels using the GRADE methodology. The guideline panel formulated six strong recommendations and one conditional recommendation regarding pharmacotherapy choices among general and special populations (mental disorders and chronic obstructive lung disease [COPD]). Strong recommendations favor varenicline rather than a nicotine patch or bupropion, using varenicline even if they are not ready to quit, using extended pharmacotherapy (>12 weeks) rather than standard treatment (8-12 weeks), or using pharmacotherapy for individuals with mental disorders or COPD. The conditional recommendation suggests combining varenicline with a nicotine patch instead of using varenicline alone. Aligned with the Korean Society of Medicine's clinical guideline development process, this is South Korea's first domestic smoking cessation treatment guideline that follows standardized guidelines. Primarily focusing on pharmacotherapy, it can serve as a foundation for comprehensive future smoking cessation clinical guidelines, encompassing broader treatment topics beyond medications.

Latin American consensus on diagnosis of gastroesophageal reflux disease.

Diagnosing gastroesophageal reflux disease (GERD) can be challenging given varying symptom presentations, and complex multifactorial pathophysiology. The gold standard for GERD diagnosis is esophageal acid exposure time (AET) measured by pH-metry. A variety of additional diagnostic tools are available. The goal of this consensus was to assess the individual merits of GERD diagnostic tools based on current evidence, and provide consensus recommendations following discussion and voting by experts. This consensus was developed by 15 experts from nine countries, based on a systematic search of the literature, using GRADE (grading of recommendations, assessment, development and evaluation) methodology to assess the quality and strength of the evidence, and provide recommendations regarding the diagnostic utility of different GERD diagnosis tools, using AET as the reference standard. A proton pump inhibitor (PPI) trial is appropriate for patients with heartburn and no alarm symptoms, but nor for patients with regurgitation, chest pain, or extraesophageal presentations. Severe erosive esophagitis and abnormal reflux monitoring off PPI are clearly indicative of GERD. Esophagram, esophageal biopsies, laryngoscopy, and pharyngeal pH monitoring are not recommended to diagnose GERD. Patients with PPI-refractory symptoms and normal endoscopy require reflux monitoring by pH or pH-impedance to confirm or exclude GERD, and identify treatment failure mechanisms. GERD confounders need to be considered in some patients, pH-impedance can identify supragrastric belching, impedance-manometry can diagnose rumination. Erosive esophagitis on endoscopy and abnormal pH or pH-impedance monitoring are the most appropriate methods to establish a diagnosis of GERD. Other tools may add useful complementary information.

Airway management in neonates and infants: European Society of Anaesthesiology and Intensive Care and British Journal of Anaesthesia joint guidelines

Airway management is required during general anaesthesia and is essential for life-threatening conditions such as cardiopulmonary resuscitation. Evidence from recent trials indicates a high incidence of critical events during airway management, especially in neonates or infants. It is important to define the optimal techniques and strategies for airway management in these groups. In this joint European Society of Anaesthesiology and Intensive Care (ESAIC) and British Journal of Anaesthesia (BJA) guideline on airway management in neonates and infants, we present aggregated and evidence-based recommendations to assist clinicians in providing safe and effective medical care. We identified seven main areas of interest for airway management: i) preoperative assessment and preparation; ii) medications; iii) techniques and algorithms; iv) identification and treatment of difficult airways; v) confirmation of tracheal intubation; vi) tracheal extubation, and vii) human factors. Based on these areas, Population, Intervention, Comparison, Outcomes (PICO) questions were derived that guided a structured literature search. GRADE (Grading of Recommendations, Assessment, Development and Evaluation) methodology was used to formulate the recommendations based on those studies included with consideration of their methodological quality (strong '1' or weak '2' recommendation with high 'A', medium 'B' or low 'C' quality of evidence). In summary, we recommend: 1. Use medical history and physical examination to predict difficult airway management (1C). 2. Ensure adequate level of sedation or general anaesthesia during airway management (1B). 3. Administer neuromuscular blocker before tracheal intubation when spontaneous breathing is not necessary (1C). 4. Use a videolaryngoscope with an age-adapted standard blade as first choice for tracheal intubation (1B). 5. Apply apnoeic oxygenation during tracheal intubation in neonates (1B). 6. Consider a supraglottic airway for rescue oxygenation and ventilation when tracheal intubation fails (1B). 7. Limit the number of tracheal intubation attempts (1C). 8. Use a stylet to reinforce and preshape tracheal tubes when hyperangulated videolaryngoscope blades are used and when the larynx is anatomically anterior (1C). 9. Verify intubation is successful with clinical assessment and end-tidal CO2 waveform (1C). 10. Apply high-flow nasal oxygenation, continuous positive airway pressure or nasal intermittent positive pressure ventilation for postextubation respiratory support, when appropriate (1B).

Clinical Effectiveness of Artificial Disc Replacement in Comparison With Anterior Cervical Discectomy and Fusion in the Patients With Cervical Myelopathy: Systematic Review and Meta-analysis.

Cervical myelopathy (CM) describes the compressive cervical spinal cord state, often accompanied by serious clinical condition, by herniated disc or hypertrophied spurs or ligament. Anterior cervical discectomy and fusion (ACDF) has been frequently employed as conventional surgical solution for this CM despite its inherent biomechanical handicap. Alternatively, an artificial disc replacement (ADR) preserves cervical motion while still decompressing the spinal canal and neural foramen. This analysis elaborated to clarify the potential benefits of ADR application to CM over ACDF from the conglomerated results of the past references. A literature search was performed using MEDLINE, Embase, Cochrane review, and KMbase databases from the studies published until March 2023. Six studies (3 randomized controlled study [RCTs] and 3 non-RCTs) were included in a qualitative and quantitative synthesis. Data were extracted and analyzed using a random effects model to obtain effect size and its statistical significance. Quality assessment and evidence level were established in accordance with the GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. Among 6 studies, 2 studies showed that ADR group achieved significantly better clinical improvement than the ACDF group, while the rest 4 studies revealed no significant difference. A meta-analysis showed better clinical outcomes with or without statistical significance. The level of evidence was low because of inconsistency and imprecision. ADR was superior or at least, not inferior to ACDF in terms of functional recovery. However, its application to the CM patients is merely empowered with weak strength due to low level of evidence.

Korean Urologic Oncology Society Guidelines: Does Angioembolization Improve the Quality of Life for Renal Cell Carcinoma Patients With Intractable Symptoms Who Are Unfit for Surgery?

Purpose: There is a lack of guidelines for using angioembolization to manage renal cell carcinoma (RCC) patients with intractable symptoms. Therefore, the Korean Urologic Oncology Society (KUOS) developed a set of recommendations for angioembolization for RCC patients with intractable symptoms who are unfit for surgery.Materials and Methods: A rigorous systematic review was performed and GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology was used to rate the certainty of the evidence for the patient outcomes and to develop the evidence into recommendations. The steering group, guidelines development group, systematic review team, and external review group consisted of KUOS members involved in the guideline development process.Results: The guidelines address the benefits, harms, patients’ values and preferences, costs, and resources related to angioembolization by using a single clinical question: Does angioembolization improve the quality of life for RCC patients with intractable symptoms who are unfit for surgery?Conclusions: The guideline development panel suggests angioembolization for RCC patients with intractable symptoms compared with supportive therapies, including systemic treatment (very low certainty of evidence, weak recommendation).

Diagnostic and prognostic value of echocardiography in pulmonary hypertension: an umbrella review of systematic reviews and meta-analyses

BackgroundThe role of echocardiography in the diagnostic and prognostic assessment of pulmonary hypertension (PH) has been widely studied recently. However, these findings have not undergone normative evaluation and may provide confusing evidence for clinicians. To evaluate and summarize existing evidence, we performed an umbrella review.MethodsSystematic reviews and meta-analyses were searched in PubMed, Embase, Web of Science, and Cochrane Library from inception to September 4, 2022. The methodological quality of the included studies was assessed using Assessment of Multiple Systematic Reviews (AMSTAR), and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to evaluate the quality of evidence.ResultsThirteen meta-analyses (nine diagnostic and four prognostic studies) were included after searching four databases. The methodological quality of the included studies was rated as high (62%) or moderate (38%) by AMSTAR. The thirteen included meta-analyses involved a total of 28 outcome measures. The quality of evidence for these outcomes were high (7%), moderate (29%), low (39%), and very low (25%) using GRADE methodology. In the detection of PH, the sensitivity of systolic pulmonary arterial pressure is 0.85–0.88, and the sensitivity and specificity of right ventricular outflow tract acceleration time are 0.84. Pericardial effusion, right atrial area, and tricuspid annulus systolic displacement provide prognostic value in patients with pulmonary arterial hypertension with hazard ratios between 1.45 and 1.70. Meanwhile, right ventricular longitudinal strain has independent prognostic value in patients with PH, with a hazard ratio of 2.96–3.67.ConclusionThe umbrella review recommends echocardiography for PH detection and prognosis. Systolic pulmonary arterial pressure and right ventricular outflow tract acceleration time can be utilized for detection, while several factors including pericardial effusion, right atrial area, tricuspid annular systolic displacement, and right ventricular longitudinal strain have demonstrated prognostic significance.Trial registrationPROSPERO (CRD42022356091), https://www.crd.york.ac.uk/prospero/.

Consenso para el tratamiento de la infección de vías urinarias altas durante la gestación

To generate evidence-based recommendations through formal consensus regarding the treatment of upper urinary tract infections during gestation. Experts in microbiology, public health, internal medicine, infectious diseases, obstetrics, maternal fetal medicine and obstetric and gynecological infections participated in the consensus development group. The group also included professionals with training in clinical epidemiology, systematic data search, and representatives from the Health Secretariat and the Bogota Obstetrics and Gynecology Association. The participants disclosed their conflicts of interest. Starting with a clinical question, outcomes were graded and a systematic search was conducted in the Medline via PubMed, Embase, Lilacs, and Bireme databases. The search was expanded to include institutional repositories and antimicrobial resistance surveillance systems, with no language or date restrictions. The search was updated on October 1, 2022. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology was used to assess the quality of the evidence and determine the strength of the recommendations. Finally, the RAND/UCLA (Research and Development/University of California Los Angeles) methodology was applied for the formal consensus. This document was reviewed by academic peers before publication. The following are the consensus recommendations. Recommendation 1. The initial management of pregnant women with upper urinary tract infections (UTIs) should be approached in a hospital setting. Recommendation 2. The use of second generation cephalosporins is the suggested first option for empirical antimicrobial management in pregnant women with upper UTI in order to improve the rates of clinical and microbiological cure. Recommendation 3. Because of the risk-benefit balance, the use of aminoglycosides is suggested as a second option for empirical antimicrobial treatment in pregnant women presenting with upper UTIs in the second and third trimester. Recommendation 4. The use of third-generation cephalosporins is suggested as the third option for empirical antimicrobial treatment in pregnant women with upper UTIs given that the risk of inducing microbial resistance is high with this group of antibiotics. Recommendation 5. The use of carbapenems is suggested as a first option in pregnant women with upper UTIs and a history of infections caused by microorganisms with resistance to third or fourth-generation cephalosporins. Recommendation 6. The use of aminoglycosides or fourth-generation cephalosporins is suggested as a second option in pregnant women with upper UTIs and a history of infection caused by microorganisms with resistance to third-generation cephalosporins, taking risk-benefit into account. Recommendation 7. The use of piperacillin/tazobactam is suggested as a third option in pregnant women with upper UTIs and a history of infection caused by microorganisms with resistance to third or fourthgeneration cephalosporins. Recommendation 8. Getting a urine culture is recommended in pregnant women with upper UTIs before initiating empirical antimicrobial treatment. Recommendation 9. In pregnant women with upper UTIs, it is suggested to modify therapy in accordance with the results of the sensitivity test when the culture report shows resistance to the antimicrobial agent initiated empirically. Recommendation 10. In pregnant women hospitalized due to upper UTIs, it is suggested to switch to oral antimicrobial therapy after at least 48 hours of modulation of the systemic inflammatory response and the clinical signs of infection, and when tolerance to oral intake is adequate. Recommendation 11. In pregnant women with upper UTIs with no complications secondary to the primary infection, it is recommended to administer antibiotic therapy for a period of 7 to 10 days. It is expected that with this Colombian upper UTI consensus variability in clinical practice will be reduced. It is recommended that groups doing research in maternal fetal medicine assess the implementation and effectiveness of these recommendations.

Clinical practice guidelines: management of severe bronchiolitis in infants under 12months old admitted to a pediatric critical care unit.

We present guidelines for the management of infants under 12months of age with severe bronchiolitis with the aim of creating a series of pragmatic recommendations for a patient subgroup that is poorly individualized in national and international guidelines. Twenty-five French-speaking experts, all members of the Groupe Francophone de Réanimation et Urgence Pédiatriques (French-speaking group of paediatric intensive and emergency care; GFRUP) (Algeria, Belgium, Canada, France, Switzerland), collaborated from 2021 to 2022 through teleconferences and face-to-face meetings. The guidelines cover five areas: (1) criteria for admission to a pediatric critical care unit, (2) environment and monitoring, (3) feeding and hydration, (4) ventilatory support and (5) adjuvant therapies. The questions were written in the Patient-Intervention-Comparison-Outcome (PICO) format. An extensive Anglophone and Francophone literature search indexed in the MEDLINE database via PubMed, Web of Science, Cochrane and Embase was performed using pre-established keywords. The texts were analyzed and classified according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. When this method did not apply, an expert opinion was given. Each of these recommendations was voted on by all the experts according to the Delphi methodology. This group proposes 40 recommendations. The GRADE methodology could be applied for 17 of them (3 strong, 14 conditional) and an expert opinion was given for the remaining 23. All received strong approval during the first round of voting. These guidelines cover the different aspects in the management of severe bronchiolitis in infants admitted to pediatric critical care units. Compared to the different ways to manage patients with severe bronchiolitis described in the literature, our original work proposes an overall less invasive approach in terms of monitoring and treatment.

Minimally Invasive Compared With Open Surgery in High-Risk Endometrial Cancer: A Systematic Review and Meta-analysis.

To compare outcomes between minimally invasive surgery and open surgery in patients with high-risk endometrial cancer. A cohort study of all patients who underwent surgery for high-risk endometrial cancer between 1999 and 2016 at Mayo Clinic (Rochester, Minnesota) and a literature search of MEDLINE, EMBASE, ClinicalTrials.gov, Cochrane Central Register of Controlled Trials, and Scopus of all published studies until December 2020. The systematic review identified 2,332 patients (14 studies, all retrospective except a subanalysis of a randomized comparison) and the cohort study identified 542 additional patients. Articles were included if reporting original data on overall survival and disease-free survival among patients with high-risk endometrial cancer, defined as International Federation of Gynecology and Obstetrics grade 3 endometrioid, serous, clear cell, mixed histology, or uterine carcinosarcoma. Studies that did not report at least one of the main outcomes, those in which one surgical technique (robotic or laparoscopic surgery) was missing in the comparison analysis with open surgery, and case reports were excluded. Additional data were extracted from a retrospective cohort of patients from Mayo. A random-effect model was used for meta-analysis. This systematic review and meta-analysis was registered in PROSPERO. Literature search and data extraction were performed independently by two reviewers, as well as quality assessment using GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology, and the Newcastle-Ottawa Scale. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. Meta-analysis showed that disease-free survival and overall survival in patients with high-risk endometrial cancer who underwent minimally invasive surgery were not statistically different from those of patients who underwent open abdominal surgery (relative risk [RR] 0.93, 95% CI 0.82-1.05, I2 20%, P=.23; and RR 0.92, 95% CI 0.77-1.11, I2 31%, P=.12, respectively). Subgroup analysis by stage (early vs advanced) did not identify a difference between surgical approaches. Minimally invasive surgery and open surgery had similar disease-free survival and overall survival in patients with high-risk endometrial cancer. PROSPERO, CRD42021275535.

226 What Is the Effect of Training on the Performance of Different Video Laryngoscope Geometries Versus Direct Laryngoscopy to Achieve First Pass Success During Emergent Tracheal Intubation? A Systematic Review and Meta-Analysis

We sought to perform a systematic review and meta-analysis of the effect of training on the performance of different video laryngoscope (VL) blade geometries to achieve first pass success (FPS) in the emergent setting in the emergency department, intensive care unit, or out-of-hospital setting. We searched MEDLINE, Embase, and Web of Science (from database inception until April, 2022) to identify observational and randomized controlled trial (RCT) studies that compared FPS among the VL blade geometries and included data on operator level of training. We excluded studies for not comparing blade geometries, studies performed in the operating theater, simulation studies, duplicate studies, and those containing no extractable data. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to assess the quality of included studies and used the Cochrane Risk of Bias Tool (RoB) to assess the risk of bias for the RCTs. Heterogeneity was assessed by the I2 statistic. Meta- analysis was performed using the Sidik and Jonkman random-effects model, and the results are reported as pooled odds ratios (OR) with 95% CI for FPS. We identified 1530 studies and excluded 1469; among the 61 included studies (75,583 total patients), 22 studies (36%) primarily had fellows or attendings in the intubating operators, 33 studies (54%) primarily had residents, and 6 (10%) primarily had out-of-hospital operators. Of the 61 studies, 10 (16.4%) were classified as having high quality evidence, 22 (36.1%) as moderate quality evidence, and 29 (47.5%) as low quality evidence using GRADE methodology. Among the 17 included RCTs, 8 (47.1%) were classified as having a low risk of bias using the RoB. In pairwise, random effects meta-analysis we found Macintosh-styled VL (MACVL) to be superior to DL for achieving FPS (OR = 1.66, 95% CI 1.36 -2.04, n = 27), as was hyperangulated VL (HAVL) (vs DL: OR = 1.82, 1.16 - 2.84, n = 27). MACVL and HAVL were comparable (OR = 0.94, 0.73 - 1.20, n = 4). For the studies with residents, MACVL was superior to DL (OR = 1.79, 1.40 - 2.28, n = 13). Similarly, for residents, HAVL was superior to DL (OR = 1.71, 1.21 - 2.42, n = 14). For the studies primarily with attendings, MACVL was comparable to DL (OR = 1.31, 0.96 - 1.77, n = 10); and for attendings, HAVL was also comparable to DL (OR = 2.34, 0.96 - 5.73, n = 11). For residents, HAVL was comparable to MACVL (OR = 0.94, 0.73 - 1.20, n = 4). There were no studies that directly compared HAVL to MACVL for attendings. Heterogeneity was moderate to high for all comparisons. Resident physicians, but not attending physicians, intubating in the emergency department, intensive care unit, and out-of-hospital settings were more likely to achieve FPS using either a MACVL or HAVL device compared to a DL device. Although our results should be interpreted with caution, this meta- analysis suggests there is either a ceiling effect of VL devices to achieve FPS when performed by attendings or that residents may be more proficient with VL devices than attendings. Future studies should report the intubating operator’s number of previous intubations to better quantify intubation experience as opposed to classifying experience based on attending or post-graduate year trainee status.

ONS Guidelines™ to Support Patient Adherence to Oral Anticancer Medications.

This evidence-based guideline intends to support patients, clinicians, and others regarding interventions and processes to support patient adherence to oral anticancer medications (OAMs). A panel of healthcare professionals and patient representatives developed a clinical practice guideline to support patients taking OAMs. GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology and criteria for trustworthy guidelines were followed. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. A quantitative or narrative synthesis of the evidence was completed. Certainty of the evidence was assessed using GRADE. The panel agreed on recommendations and suggested an adherence risk assessment, education addressing adherence, ongoing assessment, proactive follow-up, coaching, and motivational interviewing in addition to usual care. The panel suggested the implementation of a structured OAM program. As cancer treatment shifts from clinic to home settings, interventions and programs to support patients on OAMs are needed.

Development of a Clinical Practice Guideline for Lower Limb Amputees. A Knowledge Translation Process in a Middle Income Country.

Background and AimKnowledge translation processes are necessary for improving patients' and communities' health outcomes. The aim of this study was to systematically develop evidence-based recommendations for people over 16 years of age who are in risk for or have suffered a lower limb amputation for medical reasons (vascular, diabetes mellitus) or trauma (civilian or military trauma) in order to improve function, quality of life, decrease complications and morbidity.MethodsFollowing the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach we developed a Clinical Practice Guideline (CPG) for lower limb amputees with funding from the Ministry of Health in Colombia and participation of a multidisciplinary group. We included patients' preferences. Based on the scope, purposes and objectives the questions were elaborated with the PECOT strategy. The evidence search was performed for each question in the main databases: Cochrane Library, Embase and PubMed, without time limit or language restriction. Teams were formed with thematic experts and clinical epidemiologists to review the clinical studies, describe the evidence, and evaluate the quality of the body of evidence with the GRADE methodology. The recommendations were made according to the judgments proposed by the GRADE working group. We conducted a stakeholder's dialogue as a mechanism for the external validation of the guideline implementation.ResultsThe CPG included 43 recommendations related to the diagnosis, surgical treatment, rehabilitation, prescription and adaptation of the prosthesis. They were strong in favor 37.2, weak in favor 53.5, strong against 2.3, Weak against 7.0%. Quality of evidence was high in 0, moderate in 11.6, low in 58.1, and very low 30.2%.DiscussionIn 93% of the recommendations, the quality of the evidence was between low and very low. This is why it was so important to validate and discuss each recommendation with an expanded multidisciplinary group. The research group identified 25 interventions and five milestones to be prioritized in the implementation and in the stakeholder's dialogue participants identified opportunities and barriers for implementation of recommendations.ConclusionIt is necessary to develop a national policy for implementation strategies of CPG recommendations that promotes the necessary arrangements for the provision of services for diagnosis, treatment, and rehabilitation of individuals with amputations.

Effect of Postoperative Hormonal Suppression on Fertility in Patients With Endometriosis After Conservative Surgery

To evaluate the effect of hormonal suppression on fertility when administered to infertile patients or patient wishing to conceive after surgery for endometriosis. A systematic search of MEDLINE, EMBASE, CENTRAL and ClinicalTrials.gov was performed by two independent reviewers from the databases' inception until December 2020. We included randomized controlled trials comparing any suppressive hormonal therapy to an inactive control (placebo or absence of treatment) after conservative surgery for endometriosis. Studies that did not report fertility outcomes after surgery were excluded. This systematic review and meta-analysis was registered in PROSPERO. Two reviewers extracted data and assessed the risk of bias as well as the strength of evidence using GRADE (Grading of Recommendations, Assessment, Development and Evaluation) methodology. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines were followed. Relative risks (RRs) were pooled by quantitative random effect meta-analysis. From 3,138 citations, 19 trials (2,028 patients) were included. Overall, no difference was observed between the treatment and the control group for pregnancy (RR 1.15; 95% CI 1.00-1.32) and live births (RR 1.05; 95% CI 0.84-1.32). When pooling all hormonal therapies, the duration of administration of postoperative therapy was identified as a substantial source of heterogeneity between studies (I2 difference=74%) with increased chances of pregnancy compared with control when administered for at least 3 months (RR 1.22; 95% CI 1.04-1.43). Gonadotropin-releasing hormone (GnRH) agonists (14 trials, 1,721 patients) were associated with increased chances of pregnancy compared with placebo or no treatment (RR 1.20; 95% CI 1.03-1.41; I2=25%). Data were limited for other hormonal treatments with no significant difference between groups. Subgroup analyses taking into account the use of fertility treatments (insemination or in vitro fertilization), stages of the disease and risk of bias of included trials did not modify the results. Postoperative hormonal suppression should be considered on a case-by-case basis to enhance fertility while balancing this benefit with the risks of delaying conception. If chosen, GnRH agonists would be the treatment of choice, and a duration of at least 3 months should be favored. PROSPERO, CRD42021224424.

Guidelines for Reasonable and Appropriate Care in the Emergency Department 2 (GRACE-2): Low-risk, recurrent abdominal pain in the emergency department.

This second Guideline for Reasonable and Appropriate Care in the Emergency Department (GRACE-2) from the Society for Academic Emergency Medicine is on the topic "low-risk, recurrent abdominal pain in the emergency department." The multidisciplinary guideline panel applied the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of evidence and strength of recommendations regarding four priority questions for adult emergency department patients with low-risk, recurrent, undifferentiated abdominal pain. The intended population includes adults with multiple similar presentations of abdominal signs and symptoms recurring over a period of months or years. The panel reached the following recommendations: (1) if a prior negative computed tomography of the abdomen and pelvis (CTAP) has been performed within 12 months, there is insufficient evidence to accurately identify populations in whom repeat CTAP imaging can be safely avoided or routinely recommended; (2) if CTAP with IV contrast is negative, we suggest against ultrasound unless there is concern for pelvic or biliary pathology; (3) we suggest that screening for depression and/or anxiety may be performed during the ED evaluation; and (4) we suggest an opioid-minimizing strategy for pain control. EXECUTIVE SUMMARY: The GRACE-2 writing group developed clinically relevant questions to address the care of adult patients with low-risk, recurrent, previously undifferentiated abdominal pain in the emergency department (ED). Four patient-intervention-comparison-outcome-time (PICOT) questions were developed by consensus of the writing group, who performed a systematic review of the literature and then synthesized direct and indirect evidence to formulate recommendations, following GRADE methodology. The writing group found that despite the commonality and relevance of these questions in emergency care, the quantity and quality of evidence were very limited, and even fundamental definitions of the population and outcomes of interest are lacking. Future research opportunities include developing precise and clinically relevant definitions of low-risk, recurrent, undifferentiated abdominal pain and determining the scope of the existing populations in terms of annual national ED visits for this complaint, costs of care, and patient and provider preferences.

Cold application for pain and anxiety reduction following chest tube removal: A systematic review and meta-analysis.

To conduct a systematic review and meta-analysis to evaluate the effects of cold application on pain and anxiety reduction after chest tube removal (CTR). The act of removing the chest tube often causes pain among cardiothoracic surgery patients. Most guidelines regarding CTR do not mention pain management. The effects of cold application on reducing pain and anxiety after CTR are inconsistent. Systematic review and meta-analysis. We searched six databases, including Embase, Ovid Medline, Cochrane Library, Scopus, the Index to Taiwan Periodical Literature System and Airiti Library, to identify relevant articles up to the end of February 2021. We limited the language to English and Chinese and the design to randomised controlled trials (RCTs). All studies were reviewed by two independent investigators. The Cochrane Collaboration's tool was used to assess the risk of bias, Review Manager 5.4 was used to conduct the meta-analysis. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology was used for assessing certainty of evidence (CoE). Ten RCTs with 683 participants were included in the meta-analysis. The use of cold application could effectively reduce pain and anxiety after CTR. The subgroup showed that a skin temperature drops to 13°C of cold application was significantly more effective for the immediate reduction in pain intensity after CTR compared with control group. The GRADE methodology demonstrated that CoE was very low level. Cold application is a safe and easy-to-administer nonpharmacological method with immediate and persistent effects on pain and anxiety relief after CTR. Skin temperature drops to 13°C or lasts 20min of cold application were more effective for immediate reduction of pain intensity following CTR. In addition to pharmacological strategy, cold application could be used as evidence for reducing pain intensity and anxiety level after CTR.

Clinical practice guideline for the prevention and management of hypertensive disorders of pregnancy

RESUMENObjetivos: Proveer recomendaciones clínicas basadas en evidencia para la prevención y el manejo de la enfermedad hipertensiva del embarazo (EHE) en el Seguro Social de Salud (EsSalud) del Perú. Materiales y métodos: se conformó un grupo elaborador de la guía (GEG) que incluyó médicos especialistas y metodólogos. El GEG formuló ocho preguntas clínicas para ser respondidas por la presente Guía de Práctica Clínica (GPC). Se realizaron búsquedas sistemáticas de revisiones sistemáticas y, cuando se consideró pertinente, estudios primarios en PubMed y Central durante 2021. Se seleccionó la evidencia para responder cada una de las preguntas clínicas planteadas . En reuniones de trabajo periódicas, el GEG usó la metodología Grading of Recommendations Assessment, Development, and Evaluation (GRADE) para calificar la evidencia y formular las recomendaciones. Además se resentan los puntos de buenas prácticas clínicas (BPC) y los flujogramas de prevención, manejo y seguimiento. Finalmente, la GPC fue aprobada por Resolución 112-IETSI-ESSALUD-2021.Resultados: En la presente GPC se formularon 11 recomendaciones (6 fuertes y 5 condicionales) que respondieron las preguntas clínicas definidas en el alcance de la GPC, acompañadas de 32 puntos de BPC y 3 flujogramas que abordan temas de prevención, tratamiento y seguimiento de la EHE. Conclusiones: Como recomendaciones centrales de la guía se dan el uso de sulfato de magnesio para el tratamiento de la preeclampsia severa y la eclampsia. La guía deberá ser actualizada en tres años.

AGA Institute Quality Measure Development for the Management of Gastric Intestinal Metaplasia With Helicobacter pylori

AGA Institute Quality Measure Development for the Management of Gastric Intestinal Metaplasia With Helicobacter pylori

Diagnosis and Management of Acute Left-Sided Colonic Diverticulitis: A Clinical Guideline From the American College of Physicians.

The American College of Physicians (ACP) developed this guideline to provide clinical recommendations on the diagnosis and management of acute left-sided colonic diverticulitis in adults. This guideline is based on current best available evidence about benefits and harms, taken in the context of costs and patient values and preferences. The ACP Clinical Guidelines Committee (CGC) developed this guideline based on a systematic review on the use of computed tomography (CT) for the diagnosis of acute left-sided colonic diverticulitis and on management via hospitalization, antibiotic use, and interventional percutaneous abscess drainage. The systematic review evaluated outcomes that the CGC rated as critical or important. This guideline was developed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. The target audience is all clinicians, and the target patient population is adults with suspected or known acute left-sided colonic diverticulitis. ACP suggests that clinicians use abdominal CT imaging when there is diagnostic uncertainty in a patient with suspected acute left-sided colonic diverticulitis (conditional recommendation; low-certainty evidence). ACP suggests that clinicians manage most patients with acute uncomplicated left-sided colonic diverticulitis in an outpatient setting (conditional recommendation; low-certainty evidence). ACP suggests that clinicians initially manage select patients with acute uncomplicated left-sided colonic diverticulitis without antibiotics (conditional recommendation; low-certainty evidence).