Nordic Cochrane Center

Nordic, Denmark

Nordic Cochrane Center

Nordic, Denmark
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Langendam M.,University of Amsterdam | Carrasco-Labra A.,McMaster University | Carrasco-Labra A.,University of Chile | Santesso N.,McMaster University | And 12 more authors.
Journal of Clinical Epidemiology | Year: 2016

Objectives The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group has developed GRADE evidence profiles (EP) and summary of findings (SoF) tables to present evidence summaries in systematic reviews, clinical guidelines, and health technology assessments. Explanatory notes are used to explain choices and judgments in these summaries, for example, on rating of the quality of evidence. Study Design and Setting A systematic survey of the explanations in SoF tables in 132 randomly selected Cochrane Intervention reviews and in EPs of 10 guidelines. We analyzed the content of 1,291 explanations using a predefined list of criteria. Results Most explanations were used to describe or communicate results and to explain downgrading of the quality of evidence, in particular for risk of bias and imprecision. Addressing the source of baseline risk (observational data or control group risk) was often missing. For judgments about downgrading the quality of evidence, the percentage of informative explanations ranged between 41% (imprecision) and 79% (indirectness). Conclusion We found that by and large explanations were informative but detected several areas for improvement (e.g., source of baseline risk and judgments on imprecision). Guidance about explanatory footnotes and comments will be provided in the last article in this series. © 2016 Elsevier Inc. All rights reserved.


Zorzela L.,University of Alberta | Loke Y.K.,Norwich Medical School | Ioannidis J.P.,Stanford University | Golder S.,University of York | And 18 more authors.
BMJ (Online) | Year: 2016

INTRODUCTION: For any health intervention, accurate knowledge of both benefits and harms is needed. Systematic reviews often compound poor reporting of harms in primary studies by failing to report harms or doing so inadequately. While the PRISMA statement (Preferred Reporting Items for Systematic reviews and Meta-Analyses) helps systematic review authors ensure complete and transparent reporting, it is focused mainly on efficacy. Thus, a PRISMA harms checklist has been developed to improve harms reporting in systematic reviews, promoting a more balanced assessment of benefits and harms. METHODS: A development strategy, endorsed by the EQUATOR Network and existing reporting guidelines (including the PRISMA statement, PRISMA for abstracts, and PRISMA for protocols), was used. After the development of a draft checklist of items, a modified Delphi process was initiated. The Delphi consisted of three rounds of electronic feedback followed by an in-person meeting. RESULTS: The PRISMA harms checklist contains four essential reporting elements to be added to the original PRISMA statement to improve harms reporting in reviews. These are reported in the title ("Specifically mention 'harms' or other related terms, or the harm of interest in the review"), synthesis of results ("Specify how zero events were handled, if relevant"), study characteristics ("Define each harm addressed, how it was ascertained (eg, patient report, active search), and over what time period"), and synthesis of results ("Describe any assessment of possible causality"). Additional guidance regarding existing PRISMA items was developed to demonstrate relevance when synthesising information about harms. CONCLUSION: The PRISMA harms checklist identifies a minimal set of items to be reported when reviewing adverse events. This guideline extension is intended to improve harms reporting in systematic reviews, whether harms are a primary or secondary outcome. © BMJ Publishing Group Ltd 2016.


Carrasco-Labra A.,McMaster University | Carrasco-Labra A.,University of Chile | Brignardello-Petersen R.,University of Chile | Brignardello-Petersen R.,University of Toronto | And 34 more authors.
Journal of Clinical Epidemiology | Year: 2016

Objectives The current format of summary of findings (SoFs) tables for presenting effect estimates and associated quality of evidence improve understanding and assist users finding key information in systematic reviews. Users of SoF tables have demanded alternative formats to express findings from systematic reviews. Study Design and Setting We conducted a randomized controlled trial among systematic review users to compare the relative merits of a new format with the current formats of SoF tables regarding understanding, accessibility of information, satisfaction, and preference. Our primary goal was to show that the new format is not inferior to the current format. Results Of 390 potentially eligible subjects, 290 were randomized. Of seven items testing understanding, three showed similar results, two showed small differences favoring the new format, and two (understanding risk difference and quality of the evidence associated with a treatment effect) showed large differences favoring the new format [63% (95% confidence interval {CI}: 55, 71) and 62% (95% CI: 52, 71) more correct answers, respectively]. Respondents rated information in the alternative format as more accessible overall and preferred the new format over the current format. Conclusions While providing at least similar levels of understanding for some items and increased understanding for others, users prefer the new format of SoF tables. © 2016 Elsevier Inc. All rights reserved.


von Elm E.,University of Lausanne | Altman D.G.,Center for Statistics in Medicine | Egger M.,University of Bern | Egger M.,University of Cape Town | And 3 more authors.
International Journal of Surgery | Year: 2014

Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the Web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies. © 2014 The Authors.


Moher D.,Ottawa Hospital Research Institute | Moher D.,University of Ottawa | Shamseer L.,Ottawa Hospital Research Institute | Shamseer L.,University of Ottawa | And 32 more authors.
Systematic Reviews | Year: 2015

Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. We describe the development of a reporting guideline, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium. © 2015 Moher et al.


Kessel L.,Rigshospitalet Glostrup | Kessel L.,National Danish Medicines and Health Authorities | Andresen J.,Skanderborg Eye Clinic | Tendal B.,National Danish Medicines and Health Authorities | And 4 more authors.
Ophthalmology | Year: 2016

Topic We performed a systematic review and meta-analysis to evaluate the benefit and harms associated with implantation of toric intraocular lenses (IOLs) during cataract surgery. Outcomes were postoperative uncorrected distance visual acuity (UCDVA) and distance spectacle independence. Harms were evaluated as surgical complications and residual astigmatism. Clinical Relevance Postoperative astigmatism is an important cause of suboptimal UCDVA and need for distance spectacles. Toric IOLs may correct for preexisting corneal astigmatism at the time of surgery. Methods We performed a systematic literature search in the Embase, PubMed, and CENTRAL databases within the Cochrane Library. We included randomized clinical trials (RCTs) if they compared toric with non-toric IOL implantation (± relaxing incision) in patients with regular corneal astigmatism and age-related cataracts. We assessed the risk of bias using the Cochrane Risk of Bias tool. We assessed the quality of evidence across studies using the GRADE profiler software (available at: www.gradeworkinggroup.org). Results We included 13 RCTs with 707 eyes randomized to toric IOLs and 706 eyes randomized to non-toric IOLs; 225 eyes had a relaxing incision. We found high-quality evidence that UCDVA was better in the toric IOL group (logarithm of the minimum angle of resolution [logMAR] mean difference, -0.07; 95% confidence interval [CI], -0.10 to -0.04) and provided greater spectacle independence (risk ratio [RR], 0.51; 95% CI, 0.36-0.71) and moderate quality evidence that toric IOL implantation was not associated with an increased risk of complications (RR, 1.73; 95% CI, 0.60-5.04). Residual astigmatism was lower in the toric IOL group than in the non-toric IOL plus relaxing incision group (mean difference, 0.37 diopter [D]; 95% CI, -0.55 to -0.19). Conclusions We found that toric IOLs provided better UCDVA, greater spectacle independence, and lower amounts of residual astigmatism than non-toric IOLs even when relaxing incisions were used. © 2016 American Academy of Ophthalmology.


PubMed | University of Amsterdam, Cochrane Editorial Unit, Dutch Cochrane Center, McMaster University and 4 more.
Type: | Journal: Journal of clinical epidemiology | Year: 2016

The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group has developed GRADE evidence profiles (EP) and summary of findings (SoF) tables to present evidence summaries in systematic reviews, clinical guidelines, and health technology assessments. Explanatory notes are used to explain choices and judgments in these summaries, for example, on rating of the quality of evidence.A systematic survey of the explanations in SoF tables in 132 randomly selected Cochrane Intervention reviews and in EPs of 10 guidelines. We analyzed the content of 1,291 explanations using a predefined list of criteria.Most explanations were used to describe or communicate results and to explain downgrading of the quality of evidence, in particular for risk of bias and imprecision. Addressing the source of baseline risk (observational data or control group risk) was often missing. For judgments about downgrading the quality of evidence, the percentage of informative explanations ranged between 41% (imprecision) and 79% (indirectness).We found that by and large explanations were informative but detected several areas for improvement (e.g., source of baseline risk and judgments on imprecision). Guidance about explanatory footnotes and comments will be provided in the last article in this series.


Schulz K.F.,Family Health International | Altman D.G.,University of Oxford | Moher D.,Ottawa Hospital Research Institute | Berlin J.A.,Johnson and Johnson Pharmaceutical Research and Development | And 17 more authors.
Journal of Chinese Integrative Medicine | Year: 2010

The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials.

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