Systematic reviews allow health decisions to be informed by the best available research evidence. However, their number is proliferating quickly, and many skills are required to identify all the ...relevant reviews for a specific question.
We screen 10 bibliographic databases on a daily or weekly basis, to identify systematic reviews relevant for health decision-making. Using a machine-based approach developed for this project we select reviews, which are then validated by a network of more than 1000 collaborators. After screening over 1,400,000 records we have identified more than 300,000 systematic reviews, which are now stored in a single place and accessible through an easy-to-use search engine. This makes Epistemonikos the largest database of its kind.
Using a systematic approach, recruiting a broad network of collaborators and implementing automated methods, we developed a one-stop shop for systematic reviews relevant for health decision making.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The evidence on COVID-19 is being produced at high speed, so it is challenging for decision-makers to keep up. It seems appropriate, then, to put into practice a novel approach able to provide the ...scientific community and other interested parties with quality evidence that is actionable, and rapidly and efficiently produced.
We designed a protocol for multiple parallel systematic reviews and overviews of systematic reviews in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P). We will search for primary studies and systematic reviews that answer different questions related to COVID-19 using both a centralized repository (Epistemonikos database) and a manual search in MEDLINE/PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials. We will also search for literature in several other sources. At least two researchers will independently undertake the selection of studies, data extraction, and assessment of the quality of the included studies. We will synthesize data for each question using meta-analysis, when possible, and we will prepare Summary of Findings tables according to the GRADE approach. All the evidence will be organized in an open platform (L·OVE - Living OVerview of Evidence) that will be continuously updated using artificial intelligence and a broad network of experts.
No ethics approval is considered necessary. The results of these articles will be widely disseminated via peer-reviewed publications, social networks, and traditional media, and will be sent to relevant international organizations discussing this topic.
Background
This is an updated version of a Cochrane Review first published in 2014. Phimosis is a condition in which the prepuce (foreskin) cannot be fully retracted past the head of the penis ...(glans). Phimosis is often treated surgically by circumcision or prepuce plasty; however, reports of non‐invasive treatment using topical corticosteroids applied for four to eight weeks have suggested favorable outcomes.
Objectives
To assess the effects of topical corticosteroids applied to the stenotic portion of the prepuce for the treatment of phimosis in boys compared with placebo or no treatment.
Search methods
We searched CENTRAL, MEDLINE, Embase, LILACS, and ClinicalTrial.gov. We checked reference lists of included studies and relevant reviews for additional studies. There were no restrictions on the language of publication. The date of the last search was 4 October 2023.
Selection criteria
We included all randomized controlled trials (RCTs) that compared the use of any topical corticosteroid with placebo or no treatment for boys with any type or degree of phimosis.
Data collection and analysis
Two review authors independently selected studies, extracted data related to the review's primary and secondary outcomes, and assessed the studies' risk of bias. We used the random‐effects model for statistical analyses and expressed dichotomous outcomes as risk ratios (RRs) with 95% confidence intervals (CIs). We contacted the authors of the primary articles to request details of the study design and specific outcome data. We used GRADE to assess the certainty of evidence on a per‐outcome basis.
Main results
In this update, we identified two new studies with 111 participants, bringing the total number of included studies to 14 (1459 randomized participants). We found that types of corticosteroids investigated, participant age, degree of phimosis, type of phimosis, and treatment duration varied considerably among studies.
Compared with placebo or no treatment, topical corticosteroids may increase the complete resolution of phimosis after four to eight weeks of treatment (RR 2.73, 95% CI 1.79 to 4.16; I² = 72%; 10 trials, 834 participants; low‐certainty evidence). Based on 252 complete resolutions per 1000 boys in the control group, this corresponds to 436 more complete resolutions per 1000 boys (95% CI 199 more to 796 more). We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious inconsistency.
Topical corticosteroids may also increase the partial resolution of phimosis at four to eight weeks of treatment compared with placebo or no treatment (RR 1.68, 95% CI 1.17 to 2.40; I² = 44%; 7 trials, 745 participants; low‐certainty evidence). Based on 297 partial resolutions per 1000 boys in the control group, this corresponds to 202 more partial resolutions per 1000 boys (95% CI 50 more to 416 more). We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious inconsistency.
We are uncertain of the effect of topical corticosteroids compared to placebo on change in retractability score (standardized mean difference SMD −1.48, 95% CI −2.93 to −0.03; I²91%; 2 trials, 177 participants; very low‐certainty evidence). We downgraded the certainty of the evidence by one level for serious study limitations, one level for serious heterogeneity, and one level for serious imprecision.
Compared with placebo, topical corticosteroids may increase the long‐term complete resolution of phimosis six or more months after treatment (RR 4.09, 95% CI 2.80 to 5.97; I² = 0%; 2 trials, 280 participants; low‐certainty evidence). Based on 171 long‐term complete resolutions per 1000 boys in the control group, this corresponds to 528 more complete resolutions per 1000 boys (95% CI 308 more to 850 more). We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious imprecision.
There may be little or no difference in the risk of adverse effects between topical corticosteroids and placebo or no treatment (RR 0.28, 95% CI 0.03 to 2.62; I² = 22%; 11 trials, 1091 participants; low‐certainty evidence). Only two of 11 studies that recorded adverse effects reported any adverse effects; one event occurred in the corticosteroid group and six in the control group. We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious imprecision.
Authors' conclusions
Topical corticosteroids, compared to placebo or no treatment, may increase complete and partial resolution of phimosis when assessed after four to eight weeks of treatment, and may increase long‐term complete resolution of phimosis assessed six or more months after treatment. Topical corticosteroids may have few or no adverse effects, and we are uncertain about their effect on retractability scores. The body of evidence is limited by poor reporting of methods in the studies, important clinical heterogeneity, and serious imprecision in the results. Future, higher‐quality trials with long‐term follow‐up would likely improve our understanding of the effects of topical corticoids on phimosis in boys.
Background
Until recently, phimosis has been treated surgically by circumcision or prepuceplasty; however, recent reports of non‐invasive treatment using topical corticosteroids applied for four to ...eight weeks have been favourable. The efficacy and safety of topical corticosteroids for treating phimosis in boys has not been previously systematically reviewed.
Objectives
We aimed to 1) compare the effectiveness of the use of topical corticosteroid ointment applied to the distal stenotic portion of the prepuce in the resolution of phimosis in boys compared with the use of placebo or no treatment, and 2) determine the rate of partial resolution (improvement) of phimosis, rate of re‐stenosis after initial resolution or improvement of phimosis, and the rate of adverse events of topical corticosteroid treatment in boys with phimosis.
Search methods
We searched the Cochrane Renal Group's Specialised Register through contact with the Trials' Search Co‐ordinator using search terms relevant to this review. Date of last search: 16 June 2014.
Selection criteria
We included all randomised controlled trials (RCTs) that compared use of any topical corticosteroid ointment with placebo ointment or no treatment for boys with phimosis.
Data collection and analysis
Two authors independently assessed titles, s and the full‐text of eligible studies, extracted data relating to the review's primary and secondary outcomes, and assessed studies' risk of bias. Statistical analyses were performed using the random‐effects model and results were expressed as risk ratios (RR) for dichotomous outcomes with 95% confidence intervals (CI). We contacted authors of primary articles asking for details of study design and specific outcome data.
Main results
We included 12 studies that enrolled 1395 boys in this review. We found that both types of corticosteroids investigated and treatment duration varied among studies.
Compared with placebo, corticosteroids significantly increased complete or partial clinical resolution of phimosis (12 studies, 1395 participants: RR 2.45, 95% CI 1.84 to 3.26). Our analysis of studies that compared different types of corticosteroids found that these therapies also significantly increased complete clinical resolution of phimosis (8 studies, 858 participants: RR 3.42, 95% CI 2.08 to 5.62). Although nine studies (978 participants) reported that assessment of adverse effects were planned in the study design, these outcomes were not reported.
Overall, we found that inadequate reporting made assessing risk of bias challenging in many of the included studies.Selection bias, performance and detection bias was unclear in the majority of the included studies: two studies had adequate sequence generation, none reported allocation concealment; two studies had adequate blinding of participants and personnel and one had high risk of bias; one study blinded outcome assessors. Attrition bias was low in 8/12 studies and reporting bias was unclear in 11 studies and high in one study.
Authors' conclusions
Topical corticosteroids offer an effective alternative for treating phimosis in boys. Although sub optimal reporting among the included studies meant that the size of the effect remains uncertain, corticosteroids appear to be a safe, less invasive first‐line treatment option before undertaking surgery to correct phimosis in boys.
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