Asbjørn Hróbjartsson

• MD PhD MPhil
• Rigshospitalet

Importance The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in...

Importance The protocol of a randomized trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in...

Importance The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in...

Background Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of report...

Importance Well-designed and properly executed randomized trials are considered the most reliable evidence on the benefits of health care interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of repor...

Background Peer review may improve the quality of research manuscripts and aid in editorial decisions, but reviewers can have conflicts of interest that impact on their recommendations. Objectives The objective was to systematically map and describe the extent and nature of empirical research on peer reviewers’ conflicts of interest in biomedical...

Objectives: To identify, summarise, and analyse published comments relevant to the PRISMA-P (Preferred Items for Reporting Systematic reviews and Meta-Analyses Protocols) 2015 reporting guideline for systematic review protocols, with special emphasis on suggestions for guideline modifications.Methods: We included documents (e.g., empirical studies...

Routinely collected health data (RCD) including electronic health records, disease registries, health administrative data and wearables data are not specifically collected for research purposes. Analysis of these data poses unique methodological challenges that must be addressed when conducting research, particularly as availability and use increas...

Introduction An important mechanism of research waste is inadequate incorporation of, and references to, previous relevant research. Identifying references for a research manuscript can be challenging, in part due to the exponential rise in potentially relevant literature to consider. For large research projects, such as developing or updating repo...

Background Observational epidemiologic studies provide critical data for the evaluation of the potential effects of environmental, occupational and behavioural exposures on human health. Systematic reviews of these studies play a key role in informing policy and practice. Systematic reviews should incorporate assessments of the risk of bias in resu...

Background Network meta-analyses can be valuable for decision-makers in guiding clinical practice. However, for network meta-analysis results to be reliable, the assumptions of both transitivity and coherence must be met, and the methodology should adhere to current best practices. We aimed to assess whether network meta-analyses of randomized cont...

Objective: To compare the contemporary Cochrane review approach for retrieving information on trial funding and researchers' conflicts of interest with a structured approach for information retrieval. Study design and setting: Methodological study of 100 Cochrane reviews from October to December 2020 and one randomly selected trial from each rev...

Background: It has been reported that people with COVID-19 and pre-existing autoantibodies against type I interferons are likely to develop an inflammatory cytokine storm responsible for severe respiratory symptoms. Since interleukin 6 (IL-6) is one of the cytokines released during this inflammatory process, IL-6 blocking agents have been used for...

Background: An estimated 60% of pharmacological randomised trials use placebo control interventions to blind (i.e. mask) participants. However, standard placebos do not control for perceptible non-therapeutic effects (i.e. side effects) of the experimental drug, which may unblind participants. Trials rarely use active placebo controls, which conta...

Objective: To assess how much protocols reduce methodological flexibility and variation of results in meta-analyses comparing operative with non-operative treatments for proximal humerus fractures. Study design and setting: Meta-epidemiological study. We searched four bibliographic databases for eligible meta-analyses. We contacted the authors o...

A systematic review identifies, appraises and synthesises all the empirical evidence from studies that meet prespecified eligibility criteria to answer a specific research question. As part of the appraisal, researchers use explicit methods to assess risk of bias in the results’ from included studies that contribute to the review’s findings, to imp...

Objectives: To identify, summarize, and analyse comments on the core reporting guidelines for protocols of randomized trials (Standard Protocol Items: Recommendations for Interventional Trials [SPIRIT] 2013) and for completed trials (Consolidated Standards of Reporting Trials [CONSORT] 2010), with special emphasis on suggestions for guideline modi...

RESUMO A declaração dos Principais Itens para Relatar Revisões Sistemáticas e Meta-análises (PRISMA), publicada em 2009, foi desenvolvida para ajudar revisores sistemáticos a relatar de forma transparente por que a revisão foi feita, os métodos empregados e o que os autores encontraram. Na última década, os avanços na metodologia e terminologia de...

Background: Different forms of vaccines have been developed to prevent the SARS-CoV-2 virus and subsequent COVID-19 disease. Several are in widespread use globally. OBJECTIVES: To assess the efficacy and safety of COVID-19 vaccines (as a full primary vaccination series or a booster dose) against SARS-CoV-2. Search methods: We searched the Cochra...

Objective To identify, characterize, and explore author guides on the role, format, and content of protocols for observational epidemiological studies, particularly cohort and case-control studies. Study design and setting Scoping review. We searched for guides in Medline, Embase, Google Scholar, 10 general medical and epidemiological/public healt...

Objective: To identify, summarise, and analyse comments on the core reporting guidelines for protocols of randomised trials (SPIRIT 2013) and for completed trials (CONSORT 2010), with special emphasis on suggestions for guideline modifications.Methods: We included documents written in English and published after 2010 that explicitly commented on SP...

We investigated to which degree commercial funding is associated with estimated intervention effects in randomized trials. We included meta‐epidemiological studies with published data on the association between commercial funding and results or conclusions of randomized trials. We searched five databases and other sources. We selected one result pe...

Results from clinical trials can be deemed trustworthy only if they are properly conducted and their methods are fully reported. The SPIRIT and CONSORT checklists, which have improved clinical trial design, conduct and reporting, are being updated to reflect recent advances and improve the assessment of healthcare interventions.

Objective To investigate to which degree systematic review protocols adhere to the PRISMA-P reporting guideline. Study Design and Setting We randomly sampled 50 publications of systematic review protocols indexed in PubMed and 50 protocols uploaded to PROSPERO from 2016 onwards. Two authors independently extracted data and assessed adherence to th...

Clinical trials are experiments in human beings. Findings from these experiments, either by themselves or within research syntheses, are often meant to evidence-based clinical decision-making. These decisions can be misled when clinical trials are reported in a biased manner. For clinical trials to inform healthcare decisions without bias, their re...

Background: Control interventions in randomised trials provide a frame of reference for the experimental interventions and enable estimations of causality. In the case of randomised trials assessing patients with mental health disorders, many different control interventions are used, and the choice of control intervention may have considerable imp...

Background: Interleukin-1 (IL-1) blocking agents have been used for treating severe coronavirus disease 2019 (COVID-19), on the premise that their immunomodulatory effect might be beneficial in people with COVID-19. Objectives: To assess the effects of IL-1 blocking agents compared with standard care alone or with placebo on effectiveness and sa...

Objective : To investigate the association between methodological quality and reported conclusions of meta-analyses comparing operative with non-operative treatments for proximal humeral fractures. Study design and setting : Cross-sectional meta-epidemiological study. We searched EMBASE, PubMed, The Cochrane Library, and Web of Science for systema...

Introduction Randomised trials are often funded by commercial companies and methodological studies support a widely held suspicion that commercial funding may influence trial results and conclusions. However, these studies often have a risk of confounding and reporting bias. The risk of confounding is markedly reduced in meta-epidemiological studie...

Importance Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modific...

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update t...

The methods and results of systematic reviews should be reported in sufficient detail to allow users to assess the trustworthiness and applicability of the review findings. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement was developed to facilitate transparent and complete reporting of systematic reviews an...

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update t...

Background: Interleukin 6 (IL-6) blocking agents have been used for treating severe coronavirus disease 2019 (COVID-19). Their immunosuppressive effect might be valuable in patients with COVID-19 characterised by substantial immune system dysfunction by controlling inflammation and promoting disease tolerance. Objectives: To assess the effect of...

Background: This systematic review aims to estimate the proportion of medical schools and teaching hospitals with conflicts of interest (COI) policies for health research and education, to describe the provisions included in the policies and their impact on research outputs and educational quality or content. Methods: Experimental and observatio...

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update t...

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update t...

Background: Coronary heart disease is the leading cause of mortality worldwide with approximately 7.4 million deaths each year. People with established coronary heart disease have a high risk of subsequent cardiovascular events including myocardial infarction, stroke, and cardiovascular death. Antibiotics might prevent such outcomes due to their a...

Objective: To investigate the association between conflicts of interest and favourable recommendations in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews. Design: Systematic review. Eligibility criteria: Studies that compared the association between conflicts of interest and favourable recommendations of...

Background Treatment and diagnostic recommendations are often made in clinical guidelines, reports from advisory committee meetings, opinion pieces such as editorials, and narrative reviews. Quite often, the authors or members of advisory committees have industry ties or particular specialty interests which may impact on which interventions are rec...

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To provide a living mapping of registered randomized trials, and to assess and rank where appropriate the relative effects of interventions for the prevention and treatment of COVID-19. Our approach has been described in Boutron 2020 and Nguyen 2020...

Objective To characterise and analyse the experiences of trial researchers of if and how conflicts of interest had unduly influenced clinical trials they had worked on, what management strategies they had used to minimise any potential influence, and their experiences and views on conflicts of interest more generally. Design Qualitative interview...

Objectives: Researchers worldwide are actively engaging in research activities to search for preventive and therapeutic interventions against coronavirus disease 2019 (COVID-19). Our aim was to describe the planning of randomized controlled trials (RCTs) in terms of timing related to the course of the COVID-19 epidemic and research question evaluat...

Objectives Researchers worldwide are actively engaging in research activities to search for preventive and therapeutic interventions against coronavirus disease 2019 (COVID-19). Our aim was to describe the planning of randomized controlled trials (RCTs) in terms of timing related to the course of the COVID-19 epidemic and research question evaluate...

Background: The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) Statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did and what they found. Over the last decade, there have been many advances in systematic review methodology and terminolo...

The methods and results of systematic reviews should be reported in sufficient detail to allow users to assess the trustworthiness and applicability of the review findings. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement was developed to facilitate transparent and complete reporting of systematic reviews an...

Background: The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) Statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did and what they found. Over the last decade, there have been many advances in systematic review methodology and terminolo...

The methods and results of systematic reviews should be reported in sufficient detail to allow users to assess the trustworthiness and applicability of the review findings. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement was developed to facilitate transparent and complete reporting of systematic reviews an...

Background Randomised trials included in meta-analyses are often affected by bias caused by methodological flaws or limitations, but the degree of bias is unknown. Two proposed methods adjust trial results for bias using: (1) empirical evidence from published meta-epidemiological studies; or (2) expert opinion. Methods We investigated agreement be...

Objectives To study the impact of blinding on estimated treatment effects, and their variation between trials; differentiating between blinding of patients, healthcare providers, and observers; detection bias and performance bias; and types of outcome (the MetaBLIND study). Design Meta-epidemiological study. Data source Cochrane Database of Syste...

Randomized clinical trials underpin evidence‐based clinical practice, but flaws in their conduct may lead to biased estimates of intervention effects and hence invalid treatment recommendations. The main approach to the empirical study of bias is to collate a number of meta‐analyses and, within each, compare the results of trials with and without a...

Objective: To identify and summarise 1) appraisal tools and other guides which address conflicts of interest in medical research studies; and 2) top journals with policies on managing conflicts of interest in journal papers. Study design and setting: Systematic review. We searched bibliographic databases, other sources and websites of 30 top med...

The revised edition of the Handbook offers the only guide on how to conduct, report and maintain a Cochrane Review. The second edition of The Cochrane Handbook for Systematic Reviews of Interventions contains essential guidance for preparing and maintaining Cochrane Reviews of the effects of health interventions. Designed to be an accessible resou...

Assessment of risk of bias is regarded as an essential component of a systematic review on the effects of an intervention. The most commonly used tool for randomised trials is the Cochrane risk-of-bias tool. We updated the tool to respond to developments in understanding how bias arises in randomised trials, and to address user feedback on and limi...

Background Financial conflicts of interest in systematic reviews (e.g. funding by drug or device companies or authors’ collaboration with such companies) may impact on how the reviews are conducted and reported. Objectives To investigate the degree to which financial conflicts of interest related to drug and device companies are associated with re...

Background Run-in periods are occasionally used in randomized clinical trials to exclude patients after inclusion, but before randomization. In theory, run-in periods increase the probability of detecting a potential treatment effect, at the cost of possibly affecting external and internal validity. Adequate reporting of exclusions during the run-i...

This is a protocol for a Cochrane Review (Methodology). The objectives are as follows: Our objectives are to assess the beneficial effects and adverse events of placebos, usual care, and wait‐list interventions for all mental health disorders. There are three research questions: What are the beneficial effects and adverse events of: pharmacologi...

Background Recognizing the value of promoting public access to clinical trial protocols, Trials pioneered the way for their publication over a decade ago. However, despite major advances in the public accessibility of information about trial methods and results, protocol sharing remains relatively rare. Main bodyProtocol sharing facilitates the cri...

Introduction Patients in an emergency department are diverse. Some are more seriously ill than others and some even arrive in multi-organ failure. Knowledge of the prevalence of organ failure and its prognosis in unselected patients is important from a diagnostic, hospital planning, and from a quality evaluation point of view, but is not reported s...

Risk of bias assessment. (DOCX)

Organ failure definitions for each study included in the systematic review. (DOCX)

Full search for Prevalence and Prognosis of Acutely Ill Patients with Organ Failure at Arrival: A Systematic Review. (DOCX)

Full-text screening with reasons for exclusion. (DOCX)

Quality of evidence, GRADE. (DOCX)

Background: The minimum clinically important difference (MCID) is used to interpret the relevance of treatment effects, e.g. when developing clinical guidelines, evaluating trial results or planning sample sizes. There is currently no agreement on an appropriate MCID in chronic pain and little is known about which contextual factors cause variatio...

Methods to assess risk of bias in a way that is reliable, reproducible and transparent to readers, have evolved over time. Viswanathan et al. recently provided updated recommendations for assessing risk of bias in systematic reviews of health care interventions. We comment on their recommendations, and discuss new tools in development that we, as c...

This is a protocol for a Cochrane Review (Methodology). The objectives are as follows: The primary objectives are to investigate to what degree: funding of systematic reviews by drug, device, and imaging companies and authors' other financial conflicts of interest are associated with effect size estimate; and funding of systematic reviews by drug,...

Background Acutely ill patients are a heterogeneous group, and some of these suffer from organ failure. As the prognosis of organ failure improves with early treatment, it is important to identify these patients as early as possible. Most studies on organ failure have been performed in intensive care settings, or on selected groups of patients, whe...