Uncovering gaps in GRADE reporting of Eastern Association for the Surgery of Trauma (EAST) guidelines.

OBJECTIVES: To formally evaluate the uptake and reporting of the Grading of Recommendation Assessments, Development and Evaluation (GRADE) approach in clinical practice guidelines (CPGs) developed by the Eastern Association for the Surgery of Trauma (EAST). STUDY DESIGN AND SETTING: Based on an a priori, written protocol, we developed a dedicated data abstraction form that included the six suggested criteria for using and applying GRADE. By searching the EAST website, we identified all EAST guidelines that referenced the use of GRADE. All steps of the data abstraction process were completed independently and in duplicate by two members of the research team. RESULTS: We identified a total of 48 CPGs that used GRADE. Trauma and violence prevention (n = 11; 23.9%) was the most common topic. The median number of patient/population, intervention, comparison, and outcomes (PICO) questions addressed was 3 (interquartile range: 2; 4) with a median of 2.5 (interquartile range: 1; 4) critical outcomes. A conditional/weak recommendation was provided for n = 79 (51.4%) PICOs, whereas a strong recommendation was provided for 33 PICOs (23.9%). For 22 PICOs (15.9%), no recommendation was made. Nearly all guideline documents provided search dates (n = 44; 95.7%) and a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram (n = 44; 95.7%). Most described categories for rating down (n = 35; 76.1%). GRADE decision-making domains related to the ratio of benefits to harms, values and preferences, and resource utilization were referenced by 43.5% (n = 20), 43.5% (n = 20), and 30.4% (n = 14) of CPGs, respectively. For nearly half of PICO questions (n = 59; 44.2%) authors did not provide an evidence profile or summary of findings table. Comparing time periods from 2014-2018 to 2019-2022, the proportion of recommendations with an overall certainty of evidence increased (52.4% vs 83.9%; P < 0.001). CONCLUSION: EAST has successfully adopted GRADE to develop many trauma-related guidelines, each addressing a finite number of focused clinical questions based on systematic reviews conducted in-house. Overall reporting improved over time. There is for improvement when it comes to consistent provision of an overall certainty of evidence, the reporting of the evidence to decision-making process, and the justification of strong recommendations based on low/very low certainty evidence.

Tranexamic acid for percutaneous nephrolithotomy: an abridged Cochrane review.

OBJECTIVE: To assess the effects of tranexamic acid (TXA) in individuals with kidney stones undergoing percutaneous nephrolithotomy (PCNL). PATIENTS AND METHODS: We performed a literature search of Cochrane Library, PubMed (including MEDLINE), Embase, Scopus, Global Index Medicus, trials registries, grey literature, and conference proceedings. We included randomised controlled trials (RCTs) that compared treatment with PCNL with administration of TXA to placebo (or no TXA) for patients aged ≥18 years. Two review authors independently classified studies and abstracted data. Primary outcomes were blood transfusion, stone-free rate (SFR), thromboembolic events (TEE). We rated the certainty of evidence (CoE) according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach using a minimally contextualised approach with pre-defined thresholds for minimally clinically important differences (MCID). RESULTS: We included 10 RCTs assessing the effect of systemic TXA in PCNL vs placebo (or no TXA). Eight studies were published as full text. Based on an adjusted baseline risk of blood transfusion of 5.7%, systemic TXA may reduce blood transfusions (risk ratio [RR] 0.45, 95% confidence interval [CI] 0.27-0.76). Based on an adjusted baseline SFR of 75.7%, systemic TXA may increase SFR (RR 1.11, 95% CI 0.98-1.27). There is probably no difference in TEEs (risk difference 0.001, 95% CI -0.01 to 0.01). Systemic TXA may increase adverse events (AEs) (RR 5.22, 95% CI 0.52-52.72). Systemic TXA may have little to no effect on secondary interventions (RR 1.15, 95% CI 0.84-1.57). The CoE for most outcomes was assessed as low or very low. CONCLUSIONS: Based on a body of evidence of 10 RCTs, we found that systemic TXA in PCNL may reduce blood transfusions, major surgical complications, and hospital length of stay, as well as improve the SFR; however, it may increase AEs. These findings should inform urologists and their patients in making informed decisions about the use of TXA in the setting of PCNL.

Tranexamic acid for percutaneous nephrolithotomy.

BACKGROUND: Percutaneous nephrolithotomy (PCNL) is the gold standard for the treatment of large kidney stones but comes with an increased risk of bleeding compared to other treatments, such as ureteroscopy and shock wave lithotripsy. Tranexamic acid (TXA) is an antifibrinolytic agent that has been used to reduce bleeding complications in other settings. OBJECTIVES: To assess the effects of TXA in individuals with kidney stones undergoing PCNL. SEARCH METHODS: We performed a comprehensive literature search of the Cochrane Library, PubMed (including MEDLINE), Embase, Scopus, Global Index Medicus, trials registries, other sources of the grey literature, and conference proceedings. We applied no restrictions on the language of publication nor publication status. The latest search date was 11 May 2023. SELECTION CRITERIA: We included randomized controlled trials (RCTs) that compared treatment with PCNL with administration of TXA to placebo (or no TXA) for patients ≥ 18 years old. DATA COLLECTION AND ANALYSIS: Two review authors independently classified studies and abstracted data. Primary outcomes were: blood transfusion, stone-free rate (SFR), and thromboembolic events (TEEs). Secondary outcomes were: adverse events (AEs), secondary interventions, major surgical complications, minor surgical complications, unplanned hospitalizations or readmissions, and hospital length of stay (LOS). We performed statistical analyzes using a random-effects model. We rated the certainty of evidence (CoE) according to the GRADE approach using a minimally contextualized approach with predefined thresholds for minimally clinically important differences (MCIDs). MAIN RESULTS: We analyzed 10 RCTs assessing the effect of systemic TXA in PCNL versus placebo (or no TXA) with 1883 randomized participants. Eight studies were published as full text. One was published in abstract proceedings, but it was separated into two separate studies for the purpose of our analyzes. Average stone surface area ranged 3.45 to 6.62 cm2. We also found a single RCT published in full text assessing the effects of topical TXA in PCNL versus placebo (or no TXA) with 400 randomized participants, the results of which are further described in the review. Here we focus only on the results of TXA used systemically. Blood transfusion - Based on a representative baseline risk of 5.7% for blood transfusions taken from a large presentative observational studies, systemic TXA may reduce blood transfusions (risk ratio (RR) 0.45, 95% confidence interval (CI) 0.27 to 0.76; I2 = 28%; 9 studies, 1353 participants; low CoE). We assumed an MCID of ≥ 2%. Based on 57 participants per 1000 with placebo (or no TXA) being transfused, this corresponds to 31 fewer (from 42 fewer to 14 fewer) participants being transfused per 1000. Stone-free rate - Based on a representative baseline risk of 75.7% for SFR, systemic TXA may increase SFRs (RR 1.11, 95% CI 0.98 to 1.27; I2 = 62%; 4 studies, 603 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 757 participants per 1000 being stone free with placebo (or no TXA), this corresponds to 83 more (from 15 fewer to 204 more) stone-free participants per 1000. Thromboembolic events - There is probably no difference in TEEs (risk difference (RD) 0.00, 95% CI -0.01 to 0.01; I2 = 0%; 6 studies, 841 participants; moderate CoE). We assumed an MCID of ≥ 2%. Since there were no thromboembolic events in intervention and/or control groups in 5 out of6 studies, we opted to assess a risk difference with systemic TXA for this outcome. Adverse events - Systemic TXA may increase AEs (RR 5.22, 95% CI 0.52 to 52.72; I2 = 75%; 4 studies, 602 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 23 participants per 1000 with placebo (or no TXA) having an adverse event, this corresponds to 98 more (from 11 fewer to 1000 more) participants with adverse events per 1000. Secondary interventions - Systemic TXA may have little to no effect on secondary interventions (RR 1.15, 95% CI 0.84 to 1.57; I2 = 0%; 2 studies, 319 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 278 participants per 1000 with placebo (or no TXA) having a secondary intervention, this corresponds to 42 more (from 44 fewer to 158 more) participants with secondary interventions per 1000. Major surgical complications - Based on a representative baseline risk for major surgical complications of 4.1%, systemic TXA may reduce major surgical complications (RR 0.36, 95% CI 0.21 to 0.62; I2 = 0%; 5 studies, 733 participants; moderate CoE). We assumed an MCID of ≥ 2%. Based on 41 participants per 1000 with placebo (or no TXA) having a major surgical complication, this corresponds to 26 fewer (from 32 fewer to 16 fewer) participants with major surgical complications per 1000. Minor surgical complications - Systemic TXA may reduce minor surgical complications (RR 0.71, 95% CI 0.45 to 1.10; I2 = 76%; 5 studies, 733 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 396 participants per 1000 with placebo (or no TXA) having a minor surgical complication, this corresponds to 115 fewer (from 218 fewer to 40 more) participants with minor surgical complications per 1000. Unplanned hospitalizations or readmissions - We are very uncertain how unplanned hospitalizations or readmissions are affected (RR 1.55, 95% CI 0.45 to 5.31; I2 = not applicable; 1 study, 189 participants; very low CoE). We assumed an MCID of ≥ 2%. Hospital length of stay - Systemic TXA may reduce hospital LOS (mean difference 0.52 days lower, 95% CI 0.93 lower to 0.11 lower; I2 = 98%; 7 studies, 1151 participants; low CoE). We assumed an MCID of ≥ 0.5 days. AUTHORS' CONCLUSIONS: Based on 10 RCTs with substantial methodological limitations that lowered all CoE of effect, we found that systemic TXA in PCNL may reduce blood transfusions, major and minor surgical complications, and hospital LOS, as well as improve SFRs; however, it may increase AEs. We are uncertain about the effects of systemic TXA on other outcomes. Findings of this review should assist urologists and their patients in making informed decisions about the use of TXA in the setting of PCNL.

GRADE Reporting in Systematic Reviews Published in the Urological Literature (2009-2021).

PURPOSE: We evaluate the reporting of the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to rating the certainty of evidence in systematic reviews published in the urological literature. MATERIALS AND METHODS: Based on a predefined protocol, we identified all systematic reviews published in 5 major urological journals from 1998 to 2021 that reported the use of GRADE. Two authors performed study selection and data abstraction independently to assess reporting in accordance with established criteria for applying GRADE. RESULTS: We included 68 of 522 (13.0%) systematic reviews that reported the use of GRADE; the first was published in 2009. Approximately half were published between 2009-2018 (n=36) and the other half between 2019-2021 (n=32). Oncology (24; 35.3%) was the most common clinical topic, and the authors were mostly based in Europe (34; 50%). In their abstract, less than half of all systematic reviews (32; 47.1%) provided any certainty of evidence rating. Only 41 (60.3%) included a tabular result summary in the format of a summary of findings table (24; 35.3%) or evidence profile (17; 25.0%). Few (35.3%) addressed the GRADE certainty of evidence rating in the discussion section. Reporting did not improve over time when comparing the 2 time periods. CONCLUSIONS: Whereas GRADE is increasingly being applied for rating the certainty of evidence, systematic reviews published in the urological literature frequently have not followed established criteria for applying or using GRADE. There is a need for better training of authors and editors, as well as for a GRADE reporting checklist for systematic review authors.

The Quality of Literature Search Reporting in Systematic Reviews Published in the Urological Literature (1998-2021).

PURPOSE: We evaluate to what extent systematic reviews published in the urological literature follow best practices for the reporting of searches. MATERIALS AND METHODS: Systematic reviews addressing questions of therapy/prevention were sought out in 5 major urological journals from January 1998 to December 2021. Two members performed study selection and data abstraction independently and in duplicate. The methodological and reporting quality of these systematic reviews was assessed using operationalized criteria based on the PRISMA-S (Preferred Reporting Items for Systematic Reviews and Meta-analyses-literature search extension) and PRISMA 2020 checklists. Proportions of systematic reviews that satisfied each criterion were compared based on period (1998-2012, 2013-2016, and 2017-2021) and journal of publication. RESULTS: The search identified 483 systematic reviews that met inclusion criteria. Most systematic reviews searched 2 or more electronic databases (88.6%); few searched abstract proceedings (26.7%), clinical trial registries (15.1%), or dedicated databases of the "gray literature" (6.2%). Approximately 1 in 3 systematic reviews (32.3%) were explicit in not restricting searches by language. A few criteria demonstrated improved reporting over time including use of clinical trial registries (6.8% vs 14.4% vs 23.3%; P = .001), searches unrestricted by language (37.3% vs 49.3% vs 55.1%; P = .006), and flow diagram reporting (34.8% vs 82.9% vs 93.2%; P = .001) but not the search of abstract proceedings (28.6% vs 24.0% vs 27.3%; P = .647). Reporting characteristics across journals were similar. CONCLUSIONS: Systematic reviews published in the urological literature have considerable shortcomings regarding the reporting of their underlying search strategies. Efforts must be taken to improve search strategies in the form of better training in systematic review methods as well as the more stringent enforcement of reporting guidelines.

Lack of Gender Diversity Among Systematic Reviews Authors in the Urological Literature (1998-2021).

PURPOSE: Gender equity is a key performance metric in research, including systematic reviews, and is increasingly noted in publications. We performed this study to assess gender parity in scientific authorship of systematic reviews published in the urological literature. MATERIALS AND METHODS: We identified all published systematic reviews addressing questions of therapy/prevention in 5 major urological journals (The Journal of Urology®, European Urology, Urology, BJU International, and World Journal of Urology) from 1998 to 2021. We determined gender of first, second, corresponding, and any author as a binary variable (woman or man) using a predefined algorithm. RESULTS: We included 523 systematic reviews. The main journal contributors were European Urology (32.6%), BJU International (22.0%), and The Journal of Urology (19.5%). Slightly more than half (51.8%) of reviews included at least 1 woman coauthor, 37.5% did not, and in 10.7% it was unclear. First, second, and corresponding authors were women in 13.7%, 12.4%, and 4.7%, respectively, and the median number of women contributors was 1 (interquartile range 0-2). Women-first authorship for the time period 1998-2012 was 13.0% (P = .139), and senior authorship was 5.0% (P = .270). In 2013-2016 it was 11.0% and 4.1%, and in 2017-2021 it increased somewhat to 16.5% and 5.1% (P = .270), respectively. CONCLUSIONS: The number of women involved in systematic reviews is low and has not improved over time. Since scientific authorship is important for academic advancement, this finding may contribute to the underrepresentation of women in academic leadership positions. Efforts to improve gender diversity in urology should include more collaboration across genders.