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Background: Although operative delivery increases the risk of immediate pelvic floor trauma, no previous studies have adequately compared directly the effects of different kinds of instrumental vaginal deliveries on stress urinary incontinence and/or urgency urinary incontinence., Objective(s): The objectives of the study were to estimate and compare the impact of different kinds of vaginal deliveries, including spontaneous, vacuum, and forceps, on stress and urgency urinary incontinence., Study Design: All women aged 20 years or older, living in 1 county in Norway were invited to participate in 2 surveys addressing stress and urgency urinary incontinence using validated questions, "Do you leak urine when you cough, sneeze, laugh, or lift something heavy?" and "Do you have involuntary loss of urine in connection with sudden and strong urge to void?" with response options yes or no. Incontinence data were linked to the Medical Birth Registry of Norway. For this study, we included only women who had a history of vaginal birth(s). Case definitions for stress and urgency urinary incontinence were moderate to severe based on Sandvik Severity Index (slight, moderate, severe). We adjusted analyses for age, parity, body mass index, and time since last delivery and addressed effect modification, including an age threshold of 50 years., Results: The final analysis included 13,694 women of whom 12.7% reported stress urinary incontinence and 8.4% urgency urinary incontinence. Among women aged younger than 50 years, there was a statistically significant difference in the risk of stress urinary incontinence for forceps delivery (odds ratio, 1.42, 95% confidence interval, 1.09-1.86, absolute difference 5.0%) but not for vacuum (odds ratio, 0.80, 95% confidence interval, 0.59-1.09) when compared with spontaneous vaginal delivery. Among women aged younger than 50 years, forceps also had increased risk for stress urinary incontinence (odds ratio, 1.76, 95% confidence interval, 1.20-2.60) when compared with vacuum. There was no association of stress or urgency urinary incontinence with mode of delivery in women aged 50 years or older., Conclusion: For women aged younger than 50 years, forceps delivery is associated with significant increased long-term risk of stress urinary incontinence compared with other vaginal deliveries., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Recent systematic reviews and editorials suggest that many organizations that produce nutritional guideline recommendations do not adhere to internationally recognized standards set forth by the Institute of Medicine (IoM), Guidelines International Network (GIN), Appraisal of Guidelines Research and Evaluation (AGREE), and Grading Recommendations, Assessment, Development and Evaluation (GRADE)., Methods: The potential solution is an independent group with content expertise and skilled in the methodology of systematic reviews and practice guidelines to produce trustworthy guideline recommendations, recommendations that are supported by publication in a top tier journal. The BMJ Rapid Recommendations project has recently demonstrated the feasibility and utility of this approach. Here, we are proposing trustworthy nutritional guideline recommendations based on internationally accepted guideline development standards, recommendations that will be informed by rigorous and novel systematic reviews of the benefits and harms associated with nutritional exposures, as well as studies on the values and preferences related to dietary behaviors among members of the international community., Discussion: Adhering to international guideline standards, conducting high quality systematic reviews, and actively assessing the values and preferences of key stakeholders is expected to improve the quality of nutritional guidelines and their relevance to end-users, particularly patients and community members. We will send our work for peer review, and if found acceptable, we will publish our nutritional recommendations in top-tier general medicine journals.

Objective: To assess the effects of α-blockers compared to standard therapy or placebo for ureteric stones of ≤10 mm confirmed by imaging in adult patients presenting with symptoms of ureteric stone disease., Patients and Methods: We performed a systematic search in multiple databases and grey literature with no restrictions on the language of publication or publication status, up until November 2017. We included randomised controlled trials evaluating ureteric stone passage in adult patients that compared α-blockers with standard therapy or placebo. Two review authors were independently responsible for study selection, data extraction, and risk-of-bias assessment. We performed a meta-analysis using a random-effect model. The quality of evidence was assessed on outcome basis according to Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach., Results: We included 67 studies, with 10 509 participants overall. Of these, 15 studies with 5 787 participants used a placebo. Stone clearance: treatment with an α-blocker may result in a large increase in stone clearance (risk ratio [RR] 1.45, 95% confidence interval [CI] 1.36-1.55; low-quality evidence), corresponding to 278 more (95% CI: 223-340 more) stone clearances per 1 000 participants. For major adverse events, treatment with an α-blocker may have little effect (RR 1.25, 95% CI: 0.80-1.96; low-quality evidence), which corresponds to five more (95% CI four fewer to 19 more) major adverse events per 1 000 participants. Patients treated with α-blockers may also experience shorter stone expulsion times (mean difference [MD] -3.40 days, 95% CI: -4.17 to -2.63; low-quality evidence), use less diclofenac (MD -82.41 mg, 95% CI: -122.51 to -42.31; low-quality evidence) and likely require fewer hospitalisations (RR 0.51, 95% CI: 0.34-0.77; moderate-quality evidence). Meanwhile, the need for surgical intervention appears similar (RR 0.74, 95% CI: 0.53-1.02; low-quality evidence). Based on a pre-defined subgroup analysis (test for subgroup difference, P = 0.002), there may be a different effect of α-blockers based on stone size with RRs of 1.06 (95% CI: 0.98-1.15; P = 0.16; I² = 62%) for stones of ≤5 mm vs 1.45 (95% CI: 1.22-1.72; P < 0.0001; I² = 59%) for stones of >5 mm. We did not find evidence for possible subgroup effects based on stone location or α-blocker type., Conclusions: In patients with ureteric stones, α-blockers likely increase stone clearance but probably also slightly increase the risk of major adverse events. Subgroup analyses suggest that α-blockers may be less effective in smaller (≤5 mm) than larger stones (>5 mm)., (© 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.)

After publication of the original article [1] it was brought to our attention that author Laura Hidalgo Armas was incorrectly included as Laura Hildago Armas.

Background: The high impact of a cancer diagnosis on patients and their families and the increasing costs of cancer treatment call for optimal and efficient oncological care. To improve the quality of care and to minimize healthcare costs and its economic burden, many healthcare organizations introduce care pathways to improve efficiency across the continuum of cancer care. However, there is limited research on the effects of cancer care pathways in different settings., Methods: The aim of this systematic review and meta-analysis described in this protocol is to synthesize existing literature on the effects of oncological care pathways. We will conduct a systematic search strategy to identify all relevant literature in several biomedical databases, including Cochrane library, MEDLINE, Embase, and CINAHL. We will follow the methodology of Cochrane Effective Practice and Organisation of Care (EPOC), and we will include randomized trials, non-randomized trials, controlled before-after studies, and interrupted time series studies. In addition, we will include full economic evaluations (cost-effectiveness analyses, cost-utility analyses, and cost-benefit analyses), cost analyses, and comparative resource utilization studies, if available. Two reviewers will independently screen all studies and evaluate those included for risk of bias. From these studies, we will extract data regarding patient, professional, and health systems outcomes. Our systematic review will follow the PRISMA set of items for reporting in systematic reviews and meta-analyses., Discussion: Following the protocol outlined in this article, we aim to identify, assess, and synthesize all available evidence in order to provide an evidence base on the effects of oncological care pathways as reported in the literature., Systematic Review Registration: PROSPERO CRD42017057592 .

Treatment decisions are challenging in patients with metastatic castration-resistant prostate cancer with progression after or under docetaxel. The current review systematically searched the published literature on all treatment options, and assessed the risk of bias and quality of evidence. It found the best available evidence for effective prolongation of overall survival and progression-free survival for abiraterone acetate plus prednisone versus placebo plus prednisone and enzalutamide versus placebo. Other treatment modalities could be beneficial for individual patients by taking into consideration the: selection criteria of the randomized clinical trials, risk of bias, subgroup analyses, and quality of life and adverse events. Further research is needed to determine the sequence, timing asnd combination of different treatments., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: This study described the number and characteristics of questionnaires used to assess barriers of guideline use among physicians., Study Design and Setting: A scoping review was conducted. MEDLINE and EMBASE were searched from 2005 to June 2016. English-language studies that administered a questionnaire to assess barriers of guideline use among practicing physicians were eligible. Summary statistics were used to report study and questionnaire characteristics. Questionnaire content was assessed with a checklist of 57 known barriers., Results: Each of the 178 included studies administered a unique questionnaire. The number of questionnaires increased yearly from 2005 to 2015. Few were pilot-tested (50, 28.1%) or tested for psychometric properties (3, 1.7%). Two were based on theory. None probed for the full range of known barriers. Ten included a free-text option. The majority assessed professional barriers (177, 99.4%) but few of the 14 factors within this domain. Questionnaire characteristics did not change over time., Conclusion: Organizations administered questionnaires that were not reliable or valid and did not comprehensively assess barriers and may have selected interventions unlikely to promote guideline use. Research is needed to construct a questionnaire that is practical, adaptable, and robust and leads to the selection of interventions that support guideline use., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

The aim of this study is to systematically evaluate all available treatment options in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (mCRPC). We systematically searched PubMed, EMBASE, and the Cochrane libraries up to 1 March 2016 for peer-reviewed publications on randomised clinical trials (RCTs). RCTs were included if progression-free survival (PFS), overall survival (OS), quality of life (QoL), or adverse events (AEs) were quantitatively evaluated. We assessed the risk of bias with the Cochrane Collaboration's tool and graded the evidence with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group's approach. We included 25 articles, reporting on 10 unique RCTs describing seven different comparisons. In one RCT, a prolonged OS and PFS (high quality) were found with abiraterone and prednisone compared to placebo plus prednisone. In one RCT, a prolonged OS and PFS (high quality) were found with enzalutamide compared to placebo. In two RCTs, a prolonged OS (high and moderate quality) was found with 223 radium compared to placebo, but its effect on PFS is unknown. In three RCTs, a prolonged OS (moderate quality) was found with sipuleucel-T compared to placebo, but no prolonged PFS (low quality). In one RCT a prolonged PFS (high quality) was found with orteronel compared to placebo, but no prolonged OS (moderate quality). In one RCT, a prolonged OS (moderate quality) was found with bicalutamide compared to placebo, but its effect on PFS is unknown. In one RCT, a prolonged PFS (high quality) was found with enzalutamide compared to bicalutamide, but its effect on OS is unknown. The best evidence was found for abiraterone and enzalutamide for effective prolongation of OS and PFS to treat chemotherapy-naive patients with mCRPC. However, taking both QoL and AEs into consideration, other treatment modalities could be considered for individual patients., (© 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.)

Objectives: The aim of the study was to identify and describe strategies to prioritize the updating of systematic reviews (SRs), health technology assessments (HTAs), or clinical guidelines (CGs)., Study Design and Setting: We conducted an SR of studies describing one or more methods to prioritize SRs, HTAs, or CGs for updating. We searched MEDLINE (PubMed, from 1966 to August 2016) and The Cochrane Methodology Register (The Cochrane Library, Issue 8 2016). We hand searched abstract books, reviewed reference lists, and contacted experts. Two reviewers independently screened the references and extracted data., Results: We included 14 studies. Six studies were classified as descriptive (6 of 14, 42.9%) and eight as implementation studies (8 of 14, 57.1%). Six studies reported an updating strategy (6 of 14, 42.9%), six a prioritization process (6 of 14, 42.9%), and two a prioritization criterion (2 of 14, 14.2%). Eight studies focused on SRs (8 of 14, 57.1%), six studies focused on CGs (6 of 14, 42.9%), and none were about HTAs. We identified 76 prioritization criteria that can be applied when prioritizing documents for updating. The most frequently cited criteria were as follows: available evidence (19 of 76, 25.0%), clinical relevance (10 of 76; 13.2%), and users' interest (10 of 76; 13.2%)., Conclusion: There is wide variability and suboptimal reporting of the methods used to develop and implement processes to prioritize updating of SRs, HTAs, and CGs., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Guidelines support health care decision-making and high quality care and outcomes. However, their implementation is sub-optimal. Theory-informed, tailored implementation is associated with guideline use. Few guideline implementation studies published up to 1998 employed theory. This study aimed to describe if and how theory is now used to plan or evaluate guideline implementation among physicians., Methods: A scoping review was conducted. MEDLINE, EMBASE, and The Cochrane Library were searched from 2006 to April 2016. English language studies that planned or evaluated guideline implementation targeted to physicians based on explicitly named theory were eligible. Screening and data extraction were done in duplicate. Study characteristics and details about theory use were analyzed., Results: A total of 1244 published reports were identified, 891 were unique, and 716 were excluded based on title and abstract. Among 175 full-text articles, 89 planned or evaluated guideline implementation targeted to physicians; 42 (47.2%) were based on theory and included. The number of studies using theory increased yearly and represented a wide array of countries, guideline topics and types of physicians. The Theory of Planned Behavior (38.1%) and the Theoretical Domains Framework (23.8%) were used most frequently. Many studies rationalized choice of theory (83.3%), most often by stating that the theory described implementation or its determinants, but most failed to explicitly link barriers with theoretical constructs. The majority of studies used theory to inform surveys or interviews that identified barriers of guideline use as a preliminary step in implementation planning (76.2%). All studies that evaluated interventions reported positive impact on reported physician or patient outcomes., Conclusions: While the use of theory to design or evaluate interventions appears to be increasing over time, this review found that one half of guideline implementation studies were based on theory and many of those provided scant details about how theory was used. This limits interpretation and replication of those interventions, and seems to result in multifaceted interventions, which may not be feasible outside of scientific investigation. Further research is needed to better understand how to employ theory in guideline implementation planning or evaluation.

Objective: We explored how investigators of ongoing or planned trials respond to the publication of a trial stopped early for benefit addressing a similar question., Study Design and Setting: We searched multiple databases from the date of publication of the truncated trial through August, 2015. Independent reviewers selected trials and extracted data., Results: We identified 207 trials truncated for early benefit; of which 102 (49%) were followed by subsequent trials (262 subsequent trials, median 2 per truncated trial, range 1-13). Only 99 (38%) provided a rationale justifying conducting a trial despite prior stopping. The top reasons were to address different population or setting (33%), skepticism of truncated trials findings because of small sample size (12%), inconsistency with other evidence (11%), or increased risk of bias (7%). We did not identify significant associations between subsequent trials and characteristics of truncated ones (risk of bias, precision, funding, or rigor of stopping decision)., Conclusion: About half of the trials stopped early for benefit were followed by subsequent trials addressing a similar question. This suggests that future trialists may have been skeptic about the decision to stop prior trials. A more rigorous threshold for stopping early for benefit is needed., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objectives: Explicit reporting of absolute measures is important to ensure treatment effects are correctly interpreted. We examined the extent to which authors report absolute effects for patient-important outcomes in abstracts of systematic review (SR)., Study Design and Setting: We searched OVID MEDLINE and Cochrane Database of Systematic Reviews to identify eligible SRs published in the year 2010. Citations were stratified into Cochrane and non-Cochrane reviews, with repeated random sampling in a 1:1 ratio. Paired reviewers screened articles and recorded abstract characteristics, including reporting of effect measures for the most patient-important outcomes of benefit and harm., Results: We included 96 Cochrane and 94 non-Cochrane reviews. About 117 (77.5%) relative measures were reported in abstracts for outcomes of benefit, whereas only 34 (22.5%) absolute measures were reported. Similarly, for outcomes of harm, 41 (87.2%) relative measures were provided in abstracts, compared with only 6 (12.8%) absolute measures. Eighteen (9.5%) abstracts reported both absolute and relative measures for outcomes of benefit, whereas only two (1.1%) abstracts reported both measures for outcomes of harm. Results were similar between Cochrane and non-Cochrane reviews., Conclusion: SR abstracts seldom report measures of absolute effect. Journal editors should insist that authors report both relative and absolute effects for patient-important outcomes., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background & Aims: Nutritional support in the acutely ill is a complex topic. Clinical practice guidelines (CPGs) have been developed to assist healthcare professionals working in this field. However, the quality of these clinical guidelines has not yet been systematically assessed. The objective of our study was to identify and assess the quality of CPGs on nutrition in critically ill adult patients., Methods: We performed a systematic search to identify CPGs on nutrition in critically ill adult patients. Three independent appraisers assessed six domains (scope and purpose, stakeholder involvement, rigour of development, clarity of presentation, applicability and editorial independence) of the eligible CPGs using the Appraisal of Guidelines, Research, and Evaluation II (AGREE II) instrument., Results: Nine CPGs were selected. Overall agreement among appraisers was very good (ICC: 0.853; 95% CI: 0.820-0.881). The mean scores for each AGREE domain were the following: "scope and purpose" 76.2% ± 13.7%; "stakeholder involvement" 42.8% ± 16.5%; "rigour of development" 57.9% ± 18.1%; "clarity of presentation" 76.9% ± 13.7%; "applicability" 30.1% ± 22.8%; and 42.1% ± 23.9% for "editorial independence". Four CPGs were deemed "Recommended"; three "Recommended with modifications"; and two "Not recommended". We did not observe improvement over time in the overall quality of the CPGs., Conclusions: The overall quality of CPGs on nutrition in critically ill adults is suboptimal, with only four CPGs being recommended for clinical use. Our results highlight the need to revise and improve CPG development processes in this field., (Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Background: Chronic venous insufficiency (CVI) is a common condition caused by valvular dysfunction with or without associated obstruction, usually in the lower limbs. It might result in considerable discomfort with symptoms such as pain, itchiness and tiredness in the legs. Patients with CVI may also experience swelling and ulcers. Phlebotonics are a class of drugs often used to treat CVI. This is an update of a review first published in 2005., Objectives: To assess the efficacy and safety of phlebotonics administered both orally and topically for treatment of signs and symptoms of lower extremity CVI., Search Methods: For this update, the Cochrane Vascular Trials Search Co-ordinator (TSC) searched the Specialised Register (August 2015), as well as the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 7). The reference lists of the articles retrieved by electronic searches were searched for additional citations. We also contacted pharmaceutical companies and searched the World Health Organization (WHO) International Clinical Trials Registry Platform Search Portal for ongoing studies (last searched in August 2015)., Selection Criteria: Randomised, double-blind, placebo-controlled trials (RCTs) assessing the efficacy of rutosides, hidrosmine, diosmine, calcium dobesilate, chromocarbe, Centella asiatica, disodium flavodate, french maritime pine bark extract, grape seed extract and aminaftone in patients with CVI at any stage of the disease., Data Collection and Analysis: Two review authors independently extracted data and assessed the quality of included RCTs. We estimated the effects of treatment by using risk ratios (RRs), mean differences (MDs) and standardised mean differences (SMDs), according to the outcome assessed. We calculated 95% confidence interval (CIs) and percentage of heterogeneity (I(2)). Additionally, we performed sensitivity analyses., Main Results: We included 66 RCTs of oral phlebotonics, but only 53 trials provided quantifiable data (involving 6013 participants; mean age 50 years) for the efficacy analysis: 28 for rutosides, 10 hidrosmine and diosmine, nine calcium dobesilate, two Centella asiatica, two aminaftone, two french maritime pine bark extract and one grape seed extract. No studies evaluating topical phlebotonics, chromocarbe, naftazone or disodium flavodate fulfilled the inclusion criteria.Moderate-quality evidence suggests that phlebotonics reduced oedema in the lower legs compared with placebo. Phlebotonics showed beneficial effects among participants including reduced oedema (RR 0.70, 95% CI 0.63 to 0.78; I(2) = 20%; 1245 participants) and ankle circumference (MD -4.27 mm, 95% CI -5.61 to -2.93 mm; I(2) = 47%; 2010 participants). Low-quality evidence reveals no difference in the proportion of ulcers cured with phlebotonics compared with placebo (RR 0.94, 95% CI 0.79 to 1.13; I(2) = 5%; 461 participants). In addition, phlebotonics showed greater efficacy for trophic disorders, cramps, restless legs, swelling and paraesthesia, when compared with placebo. We identified heterogeneity for the variables of pain, itching, heaviness, quality of life and global assessment by participants. For quality of life, it was not possible to pool the studies because heterogeneity was high. However, high-quality evidence suggests no differences in quality of life for calcium dobesilate compared with placebo (MD -0.60, 95% CI -2.15 to 0.95; I(2) = 40%; 617 participants), and low-quality evidence indicates that in the aminaftone group, quality of life was improved over that reported in the placebo group (MD -10.00, 95% CI -17.01 to - 2.99; 79 participants). Moderate-quality evidence shows that the phlebotonics group had greater risk of non-severe adverse events than the placebo group (RR 1.21, 95% CI 1.05 to 1.41; I(2) = 0; 3975 participants). Gastrointestinal disorders were the most frequently reported adverse events., Authors' Conclusions: Moderate-quality evidence shows that phlebotonics may have beneficial effects on oedema and on some signs and symptoms related to CVI such as trophic disorders, cramps, restless legs, swelling and paraesthesia when compared with placebo but can produce more adverse effects. Phlebotonics showed no differences compared with placebo in ulcer healing. Additional high-quality RCTs focused on clinically important outcomes are needed to improve the evidence base.

Objectives: Expressing treatment effects in relative terms yields larger numbers than expressions in absolute terms, affecting the judgment of the clinicians and patients regarding the treatment options. It is uncertain how authors of systematic reviews (SRs) absolute effect estimates are reported in. We therefore undertook a systematic survey to identify and describe the reporting and methods for calculating absolute effect estimates in SRs., Study Design and Setting: Two reviewers independently screened title, abstract, and full text and extracted data from a sample of Cochrane and non-Cochrane SRs. We used regression analyses to examine the association between study characteristics and the reporting of absolute estimates for the most patient-important outcome., Results: We included 202 SRs (98 Cochrane and 104 non-Cochrane), most of which (92.1%) included standard meta-analyses including relative estimates of effect. Of the 202 SRs, 73 (36.1%) reported absolute effect estimates for the most patient-important outcome. SRs with statistically significant effects were more likely to report absolute estimates (odds ratio, 2.26; 95% confidence interval: 1.08, 4.74). The most commonly reported absolute estimates were: for each intervention, risk of adverse outcomes expressed as a percentage (41.1%); number needed to treat (26.0%); and risk for each intervention expressed as natural units or natural frequencies (24.7%). In 12.3% of the SRs that reported absolute effect estimates for both benefit and harm outcomes, harm outcomes were reported exclusively as absolute estimates. Exclusively reporting of beneficial outcomes as absolute estimates occurred in 6.8% of the SRs., Conclusions: Most SRs do not report absolute effects. Those that do often report them inadequately, thus requiring users of SRs to generate their own estimates of absolute effects. For any apparently effective or harmful intervention, SR authors should report both absolute and relative estimates to optimize the interpretation of their findings., (Copyright © 2016 Elsevier Inc. All rights reserved.)