To compare A Measurement Tool to Assess Systematic Reviews (AMSTAR 2) with a tool to assess risk of bias in systematic reviews (ROBIS) in terms of validity, reliability, and applicability.
We ...analyzed 30 systematic reviews (SRs) that included randomized and nonrandomized studies, with Cochrane and non-Cochrane SRs sampled in 1:1 ratio. Four reviewers assessed independently all 30 SRs with AMSTAR 2, followed by ROBIS. We calculated Fleiss’ Kappa as a measure of inter-rater reliability (IRR) across 4 raters.
The IRR for scoring the overall confidence in the SRs with AMSTAR 2 and the overall domain in ROBIS was fair (AMSTAR 2: κ = 0.30, 95% confidence interval CI: 0.17 to 0.43; ROBIS: κ = 0.28, 95% CI: 0.13 to 0.42). AMSTAR 2 confidence in review ratings strongly correlated with the overall domain rating in ROBIS (Spearman rs = 0.84). Mean time for scoring AMSTAR 2 was slightly higher than for ROBIS (18 vs. 16 min), with huge differences between the reviewers.
Both AMSTAR 2 and ROBIS can be applied to SRs including both randomized controlled trials (RCTs) and non-RCTs. Measurement properties of ROBIS seemed not to be much different when comparing with other studies that include only SRs of RCTs.
Introduction: Five anti-tumor necrosis factor (anti-TNF) agents have received regulatory approval for use in rheumatology: adalimumab, golimumab, infliximab, certolizumab, and etanercept. Apart from ...their well-documented therapeutic value, it is still uncertain to what extent they are associated with an increased risk of infectious adverse events.
Areas covered: We conducted a systematic review and meta-analysis of published randomized studies to determine the effect of anti-TNF drugs on the occurrence of infectious adverse events (serious infections; tuberculosis; opportunistic infections; any infection). We searched Medline, Embase, and the Cochrane Library up to May 2014 to identify eligible studies in adult patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis that evaluated anti-TNF drugs compared with placebo or no treatment.
Expert opinion: Our study encompassed data from 71 randomized controlled trials involving 22,760 participants (range of follow-up: 1-36 months) and seven open label extension studies with 2,236 participants (range of follow-up: 6-48 months). Quantitative synthesis of the available data found statistically significant increases in the occurrence of any infections (20%), serious infections (40%), and tuberculosis (250%) associated with anti-TNF drug use, while the data for opportunistic infections were scarce. The quality of synthesized evidence was judged as moderate. Further evidence from registries and long-term epidemiological studies are needed to better define the relationship between anti-TNF agents and infection complications.
Advanced Computerized Decision Support Systems (CDSSs) assist clinicians in their decision-making process, generating recommendations based on up-to-date scientific evidence. Although this technology ...has the potential to improve the quality of patient care, its mere provision does not guarantee uptake: even where CDSSs are available, clinicians often fail to adopt their recommendations. This study examines the barriers and facilitators to the uptake of an evidence-based CDSS as perceived by diverse health professionals in hospitals at different stages of CDSS adoption.
Qualitative study conducted as part of a series of randomized controlled trials of CDSSs. The sample includes two hospitals using a CDSS and two hospitals that aim to adopt a CDSS in the future. We interviewed physicians, nurses, information technology staff, and members of the boards of directors (n = 30). We used a constant comparative approach to develop a framework for guiding implementation.
We identified six clusters of experiences of, and attitudes towards CDSSs, which we label as "positions." The six positions represent a gradient of acquisition of control over CDSSs (from low to high) and are characterized by different types of barriers to CDSS uptake. The most severe barriers (prevalent in the first positions) include clinicians' perception that the CDSSs may reduce their professional autonomy or may be used against them in the event of medical-legal controversies. Moving towards the last positions, these barriers are substituted by technical and usability problems related to the technology interface. When all barriers are overcome, CDSSs are perceived as a working tool at the service of its users, integrating clinicians' reasoning and fostering organizational learning.
Barriers and facilitators to the use of CDSSs are dynamic and may exist prior to their introduction in clinical contexts; providing a static list of obstacles and facilitators, irrespective of the specific implementation phase and context, may not be sufficient or useful to facilitate uptake. Factors such as clinicians' attitudes towards scientific evidences and guidelines, the quality of inter-disciplinary relationships, and an organizational ethos of transparency and accountability need to be considered when exploring the readiness of a hospital to adopt CDSSs.
Summary
Background
The nocebo effect is a negative effect of a pharmacological or nonpharmacological medical treatment that is induced by patients' expectations, and that is unrelated to the ...physiological action of the treatment. The nocebo effect can negatively affect treatment outcomes.
Aim
To develop evidence‐based consensus recommendations for the prevention and management of the nocebo effect in biosimilar‐treated patients with IBD.
Methods
The “NOCE‐BIO Consensus Group” was composed of 19 members from five European countries, and with different fields of expertise. A literature review on the nocebo effect, with specific focus on information about its prevention and management in biosimilar‐treated IBD patients, was performed. Preliminary statements were formulated and voted on during a consensus group meeting held in Milan, Italy, in July 2018. A statement was accepted if >75% of participants voted 4 (“agree”) or 5 (“strongly agree”) on a scale of 1‐5.
Results
Consensus was reached on 11 recommendation statements. Seven statements reached consensus after one voting round and four statements reached consensus after two voting rounds. All statements were supported by very low‐quality level of evidence. The panel agreed that patient‐health‐care provider relationship is a key driver of acceptance of biosimilars, which limits the risk of negative bias and the nocebo effect. Lack of knowledge among patients and health‐care providers about the effectiveness and safety of biosimilars should be minimized. Education about biosimilars needs to be tailored to the individual patient, and positive framing is recommended.
Conclusions
The nocebo effect is under‐recognised in the era of biosimilars, although it may negatively impact on the cost‐savings of biosimilars. Future research should focus on the magnitude, the risk factors, the impact, and the management of the nocebo effect in biosimilars‐treated IBD patients.
The objective of the study is to assess the interrater reliability (IRR) and usability of the revised Cochrane risk of bias tool for randomized trials (RoB 2).
This is a cross-sectional study. Four ...raters independently applied RoB 2 on the primary outcome of a random sample of individually randomized parallel-group trials (randomized controlled trials (RCTs)). We calculated the Fleiss’ kappa for multiple raters, the time needed to complete the tool, and discussed the application of RoB 2 to identify difficulties and reasons for disagreement.
A total of 70 outcomes from 70 RCTs were included. IRR was slight for overall judgment (IRR 0.16, 95% confidence interval (CI) 0.08–0.24); individual domain analysis gave IRR as moderate for “randomization process” (IRR 0.45, 95% CI 0.37–0.53), slight for “deviations from intended intervention” for RCTs assessing the effect of the assignment to an intervention (IRR 0.04, 95% CI −0.06 to 0.14), fair for those assessing the effect of adhering (IRR 0.21, 95% CI 0.11–0.31), and fair for the other domains, ranging from 0.22 (95% CI 0.14–0.30) for “missing outcome data” to 0.30 (95% CI 0.22–0.38) for “selection of reported results”. Mean time to apply the tool was 28 minutes (standard deviation 13.4) per study outcome. The main difficulties were due to poor knowledge of the subject matter of primary studies, new terminology, different approaches for some domains compared with the previous tool, and way of formulating signaling questions.
RoB 2 is a detailed and comprehensive tool but difficult and demanding, even for raters with substantial expertise in systematic reviews. Calibration exercises and intensive training are needed before its application, to improve reliability.
The complexity of modern practice requires health professionals to be active information-seekers.
Our aim was to review the quality and progress of point-of-care information summaries-Web-based ...medical compendia that are specifically designed to deliver pre-digested, rapidly accessible, comprehensive, and periodically updated information to health care providers. We aimed to evaluate product claims of being evidence-based.
We updated our previous evaluations by searching Medline, Google, librarian association websites, and conference proceedings from August 2012 to December 2014. We included Web-based, regularly updated point-of-care information summaries with claims of being evidence-based. We extracted data on the general characteristics and content presentation of products, and we quantitatively assessed their breadth of disease coverage, editorial quality, and evidence-based methodology. We assessed potential relationships between these dimensions and compared them with our 2008 assessment.
We screened 58 products; 26 met our inclusion criteria. Nearly a quarter (6/26, 23%) were newly identified in 2014. We accessed and analyzed 23 products for content presentation and quantitative dimensions. Most summaries were developed by major publishers in the United States and the United Kingdom; no products derived from low- and middle-income countries. The main target audience remained physicians, although nurses and physiotherapists were increasingly represented. Best Practice, Dynamed, and UptoDate scored the highest across all dimensions. The majority of products did not excel across all dimensions: we found only a moderate positive correlation between editorial quality and evidence-based methodology (r=.41, P=.0496). However, all dimensions improved from 2008: editorial quality (P=.01), evidence-based methodology (P=.015), and volume of diseases and medical conditions (P<.001).
Medical and scientific publishers are investing substantial resources towards the development and maintenance of point-of-care summaries. The number of these products has increased since 2008 along with their quality. Best Practice, Dynamed, and UptoDate scored the highest across all dimensions, while others that were marketed as evidence-based were less reliable. Individuals and institutions should regularly assess the value of point-of-care summaries as their quality changes rapidly over time.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
Data extraction from reports about experimental or observational studies is a crucial methodological step informing evidence syntheses, such as systematic reviews (SRs) and overviews of SRs. ...Reporting discrepancies were defined as pairs of statements that could not both be true. Authors of SRs and overviews of SRs can encounter reporting discrepancies among multiple sources when extracting data—a manuscript and a conference abstract, and a manuscript and a clinical trial registry. However, these discrepancies can also be found within a single manuscript published in a scientific journal.
Hereby, we describe examples of internal reporting discrepancies that can be found in a single source, with the aim of raising awareness among authors of SRs and overviews of SRs about such potential methodological issues.
Authors of SRs and overviews of SRs should check whether the same information is reported in multiple places within a study and compare that information. Independent data extraction by two reviewers increases the chance of finding discrepancies, if they exist. We provide advice on how to deal with different types of discordances and how to report such discordances when conducting SRs and overviews of SRs.
Abstract
This article is the second in a series of two publications relating to the European Crohn’s and Colitis Organisation ECCO evidence-based consensus on the management of Crohn’s disease. The ...first article covers medical management; the present article addresses surgical management, including preoperative aspects and drug management before surgery. It also provides technical advice for a variety of common clinical situations. Both articles together represent the evidence-based recommendations of the ECCO for Crohn’s disease and an update of previous guidelines.
Aims
The comparative efficacy, safety and tolerability of budesonide‐MMX and oral mesalamine in active, mild‐to‐moderate ulcerative colitis (UC) are unclear. We conducted a network meta‐analysis to ...fill this evidence gap.
Methods
We searched PubMed, Scopus, Embase, the Cochrane Library, clinical trial registries, regulatory agencies' websites and international conference proceedings, up to July 2018, to identify randomized controlled trials of adult patients with active, mild‐to‐moderate UC, comparing budesonide‐MMX or mesalamine against placebo, or against each other, or different dosing strategies, for induction of remission. Two reviewers independently ed study data and outcomes, and assessed each trial's risk‐of‐bias.
Results
We identified and synthesized evidence from 15 eligible trials including 4083 participants. Budesonide‐MMX 9 mg/day and mesalamine >2.4 g/day had similar efficacy for induction of clinical and endoscopic remission (OR = 0.97; 0.59–1.60), both showing superiority over placebo (OR = 2.68; 1.75–4.10, and OR = 2.75; 1.94–3.90, respectively). Furthermore, mesalamine >2.4 g/day was more efficacious than mesalamine 1.6–2.4 g/day (odds ratio = 1.27; 1.03–1.56). Secondary analyses showed that mesalamine >2.4 g/day ranks at the top among comparator treatments regarding safety (serious adverse events; surface under the cumulative ranking area SUCRA 79.2%) and tolerability (treatment discontinuations or withdrawals from the study due to adverse events; SUCRA 96.7%). There was no evidence of inconsistency, while heterogeneity between studies and risk of publication bias were low.
Conclusion
Budesonide‐MMX and mesalamine >2.4 g/day had similar efficacy for induction of clinical and endoscopic remission in active, mild‐to‐moderate UC; however, mesalamine >2.4 g/day showed better tolerability. Further high‐quality research is warranted.
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