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Article ; Online: Conflict of Interest Policies at Medical Schools and Teaching Hospitals

Alice Fabbri / Kristine Rasmussen Hone / Asbjørn Hróbjartsson / Andreas Lundh

International Journal of Health Policy and Management, Vol 11, Iss 8, Pp 1274-

A Systematic Review of Cross-sectional Studies

2022 Volume 1285

Abstract: 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 ... ...

Abstract	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 observational studies reporting at least one of the above mentioned aims were included irrespective of language, publication type or geographical setting. MEDLINE, Scopus, Embase and the Cochrane Methodology Register were searched from inception to March 2020. Methodological study quality was assessed using an amended version of the Joanna Briggs Institute’s checklist for prevalence studies. Results Twenty-two cross-sectional studies were included; all were conducted in high-income countries. Of these, 20 studies estimated the prevalence of COI policies, which ranged from 5% to 100% (median: 85%). Twenty studies assessed the provisions included in COI policies with different assessment methods. Of these, nine analysed the strength of the content of medical schools’ COI policies using various assessment tools that looked at a range of policy domains. The mean standardised summary score of policy strength ranged from 2% to 73% (median: 30%), with a low score indicating a weak policy. North American institutions more frequently had COI policies and their content was rated as stronger than policies from European institutions. None of the included studies assessed the impact of COI policies on research outputs or educational quality or content. Conclusion Prevalence of COI policies at medical schools and teaching hospitals varied greatly in high-income countries. No studies estimated the prevalence of policies in low to middle-income countries. The content of COI policies varied widely and while most European institutions ranked poorly, in North America more medical schools had strong policies. No studies were identified on impact of COI policies on research outputs and educational quality ...
Keywords	conflict of interest ; policies ; industry ; medical schools ; teaching hospitals ; Public aspects of medicine ; RA1-1270
Subject code	300
Language	English
Publishing date	2022-08-01T00:00:00Z
Publisher	Kerman University of Medical Sciences
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Promoting public access to clinical trial protocols

An-Wen Chan / Asbjørn Hróbjartsson

Trials, Vol 19, Iss 1, Pp 1-

challenges and recommendations

2018 Volume 7

Abstract: Abstract 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 ... ...

Abstract	Abstract 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 body Protocol sharing facilitates the critical appraisal of clinical trials and helps to identify and deter the selective reporting of outcomes and analyses. Challenges to the routine availability of high quality trial protocols include the gaps in incentives and adherence mechanisms, limited venues for sharing the original and final protocol versions, and the need for mechanisms to ensure transparent and complete protocol content. Conclusions We propose recommendations for addressing key challenges to protocol sharing in order to promote routine public access to protocols for the benefit of patients and other users of evidence from clinical trials.
Keywords	Clinical trial protocol ; Publication ; Transparency ; Selective reporting ; Medicine (General) ; R5-920
Subject code	306
Language	English
Publishing date	2018-02-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials

Segun Bello / Maoling Wei / Jørgen Hilden / Asbjørn Hróbjartsson

BMC Medical Research Methodology, Vol 16, Iss 1, Pp 1-

a methodological systematic review

2016 Volume 12

Abstract: Abstract Background Blinding is a pivotal method to avoid bias in randomised clinical trials. In blinded drug trials, experimental and control interventions are often designed to be matched, i.e. to appear indistinguishable. It is unknown how often ... ...

Abstract	Abstract Background Blinding is a pivotal method to avoid bias in randomised clinical trials. In blinded drug trials, experimental and control interventions are often designed to be matched, i.e. to appear indistinguishable. It is unknown how often matching procedures are inadequate, so we decided to systematically identify and analyse studies of matching quality in drug trials. Our primary objective was to assess the proportion of studies that concluded that the matching was inadequate; our secondary objective was to describe mechanisms for inadequate matching. Methods Systematic review. We searched PubMed, Google Scholar and Web of Science Citation Index for studies that assessed whether supposedly indistinguishable interventions (experimental and control) in randomized clinical drug trials could be distinguished based on physical properties (e.g. appearance or smell). Two persons decided on study eligibility and extracted data independently. Our primary analysis was based on the conclusions of each study. In supportive analyses, we defined a low and a high threshold for inadequate matching. We summarised results qualitatively. Results We included studies of 36 trials, of which 28 (78 %) were published before 1977. The studies differed considerably with regard to design, methodology and analysis. Sixteen of the 36 studies (44 %) concluded inadequate matching. When we adapted high or low thresholds for inadequate matching, the number of trials with inadequate matching was reduced to 12 (33 %) or increased to 26 (72 %). Inadequate matching was concluded in 7 of 22 trials (32 %) based on a defined cohort of trials. Inadequate matching was concluded in 9 of 14 trials (64 %) which were not based on a trial cohort, and therefore at a higher risk of publication bias. The proportion of inadequate matching did not seem to depend on publication year. Typical mechanisms of inadequate matching were differences in taste or colour. Conclusion We identified matching quality studies of 36 randomized clinical drug trials. ...
Keywords	Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2016-02-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Book ; Online: Interventions for preventing and treating COVID-19

Isabelle Boutron / Anna Chaimani / Joerg J Meerpohl / Asbjørn Hróbjartsson / Declan Devane / Gabriel Rada / David Tovey / Giacomo Grasselli / Philippe Ravaud

protocol for a living mapping of research and a living systematic review

2020

Abstract: WHO declared COVID-19 a pandemic on March 11, 2020. Researchers are working to accelerate the development of diagnostic tests, preventive interventions and therapeutic interventions. Many randomized trials have been established to evaluate candidate ... ...

Abstract	WHO declared COVID-19 a pandemic on March 11, 2020. Researchers are working to accelerate the development of diagnostic tests, preventive interventions and therapeutic interventions. Many randomized trials have been established to evaluate candidate therapeutic agents that may effectively reduce symptoms and avoid deaths. This emerging situation requires the optimal planning and conduct of trials as well as strategies for the appropriate translation of research into practice. Therefore, decision-makers and researchers urgently need a complete, high-quality and up-to-date synthesis of data from all ongoing research studies as soon as they are available. To this end, we will perform a living mapping of registered randomized trials and a living systematic review with pairwise meta-analyses and when possible, network meta-analyses focusing on two main questions: 1) the effectiveness of preventive interventions for COVID-19 and 2) the effectiveness of treatment interventions for COVID-19. We will evaluate the impact of these treatments considering the severity of the disease (i.e., mild, moderate, severe and critical diseases). This protocol details the process and methods we will use.
Keywords	Covid-19 ; 2019-nCoV ; SARS-CoV-2 ; covid19
Subject code	306
Language	English
Publishing date	2020-06-17
Publishing country	eu
Document type	Book ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Book ; Online: Interventions for preventing and treating COVID-19

Isabelle Boutron / Anna Chaimani / Declan Devane / Joerg J Meerpohl / David Tovey / Asbjørn Hróbjartsson / Philippe Ravaud

protocol for a living mapping of research and a living systematic review

2020

Abstract	WHO declared COVID-19 a pandemic on March 11, 2020. Researchers are working to accelerate the development of diagnostic tests, preventive interventions and therapeutic interventions. Many randomized trials have been established to evaluate candidate therapeutic agents that may effectively reduce symptoms and avoid deaths. This emerging situation requires the optimal planning and conduct of trials as well as strategies for the appropriate translation of research into practice. Therefore, decision-makers and researchers urgently need a complete, high-quality and up-to-date synthesis of data from all ongoing research studies as soon as they are available. To this end, we will perform a living mapping of registered randomized trials and a living systematic review with pairwise meta-analyses and when possible, network meta-analyses focusing on two main questions: 1) the effectiveness of preventive interventions for COVID-19 and 2) the effectiveness of treatment interventions for COVID-19. We will evaluate the impact of these treatments considering the severity of the disease (i.e., mild, moderate, severe and critical diseases). This protocol details the process and methods we will use.
Keywords	Covid-19 ; 2019-nCoV ; SARS-CoV-2 ; covid19
Subject code	306
Language	English
Publishing date	2020-05-11
Publishing country	eu
Document type	Book ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Book ; Online: Interventions for preventing and treating COVID-19

Isabelle Boutron / Anna Chaimani / Joerg J Meerpohl / Asbjørn Hróbjartsson / Declan Devane / Gabriel Rada / David Tovey / Giacomo Grasselli / Philippe Ravaud

living systematic reviews and network meta-analyses

2020

Abstract	WHO declared COVID-19 a pandemic on March 11, 2020. Researchers are working to accelerate the development of diagnostic tests, preventive interventions and therapeutic interventions. Many randomized trials have been established to evaluate candidate therapeutic agents that may effectively reduce symptoms and avoid deaths. This emerging situation requires the optimal planning and conduct of trials as well as strategies for the appropriate translation of research into practice. Therefore, decision-makers and researchers urgently need a complete, high-quality and up-to-date synthesis of data from all ongoing research studies as soon as they are available. To this end, we will perform a living mapping of registered randomized trials and a living systematic review with pairwise meta-analyses and when possible, network meta-analyses focusing on two main questions: 1) the effectiveness of preventive interventions for COVID-19 and 2) the effectiveness of treatment interventions for COVID-19. We will evaluate the impact of these treatments considering the severity of the disease (i.e., mild, moderate, severe and critical diseases). This protocol details the process and methods we will use.
Keywords	Covid-19 ; 2019-nCoV ; SARS-CoV-2 ; covid19
Subject code	610 ; 306
Language	English
Publishing date	2020-09-08
Publishing country	eu
Document type	Book ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Book ; Online: Interventions for preventing and treating COVID-19

Isabelle Boutron / Anna Chaimani / Declan Devane / Joerg J Meerpohl / David Tovey / Asbjørn Hróbjartsson / Philippe Ravaud

protocol for a living mapping of research and a living systematic review

2020

Abstract	WHO declared COVID-19 a pandemic on March 11, 2020. Researchers are working to accelerate the development of diagnostic tests, preventive interventions and therapeutic interventions. Many randomized trials have been established to evaluate candidate therapeutic agents that may effectively reduce symptoms and avoid deaths. This emerging situation requires the optimal planning and conduct of trials as well as strategies for the appropriate translation of research into practice. Therefore, decision-makers and researchers urgently need a complete, high-quality and up-to-date synthesis of data from all ongoing research studies as soon as they are available. To this end, we will perform a living mapping of ongoing randomized trials, followed by living systematic reviews with pairwise meta-analyses and when possible, network meta-analyses focusing on two main questions: 1) the effectiveness of preventive interventions for COVID-19 and 2) the effectiveness of treatment interventions for COVID-19. We will evaluate the impact of these treatments considering the severity of the disease (i.e., mild, moderate, severe and critical diseases). This protocol details the process and methods we will use.
Keywords	Covid-19 ; 2019-nCoV ; SARS-CoV-2 ; covid19
Subject code	306
Language	English
Publishing date	2020-04-08
Publishing country	eu
Document type	Book ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Mechanisms and direction of allocation bias in randomised clinical trials

Asger Paludan-Müller / David Ruben Teindl Laursen / Asbjørn Hróbjartsson

BMC Medical Research Methodology, Vol 16, Iss 1, Pp 1-

2016 Volume 10

Abstract: Abstract Background Selective allocation of patients into the compared groups of a randomised trial may cause allocation bias, but the mechanisms behind the bias and its directionality are incompletely understood. We therefore analysed the mechanisms and ...

Abstract	Abstract Background Selective allocation of patients into the compared groups of a randomised trial may cause allocation bias, but the mechanisms behind the bias and its directionality are incompletely understood. We therefore analysed the mechanisms and directionality of allocation bias in randomised clinical trials. Methods Two systematic reviews and a theoretical analysis. We conducted one systematic review of empirical studies of motives/methods for deciphering patient allocation sequences; and another review of methods publications commenting on allocation bias. We theoretically analysed the mechanisms of allocation bias and hypothesised which main factors predicts its direction. Results Three empirical studies addressed motives/methods for deciphering allocation sequences. Main motives included ensuring best care for patients and ensuring best outcome for the trial. Main methods included various manipulations with randomisation envelopes. Out of 57 methods publications 11 (19 %) mentioned explicitly that allocation bias can go in either direction. We hypothesised that the direction of allocation bias is mainly decided by the interaction between the patient allocators’ motives and treatment preference. Conclusion Inadequate allocation concealment may exaggerate treatment effects in some trials while underestimate effects in others. Our hypothesis provides a theoretical overview of the main factors responsible for the direction of allocation bias.
Keywords	Allocation bias ; Selection bias ; Bias mechanisms ; Systematic review ; Randomised clinical trials ; Direction of bias ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2016-10-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Prevalence and prognosis of acutely ill patients with organ failure at arrival to hospital

Peter Bank Pedersen / Asbjørn Hrobjartsson / Daniel Lykke Nielsen / Daniel Pilsgaard Henriksen / Mikkel Brabrand / Annmarie Touborg Lassen

PLoS ONE, Vol 13, Iss 11, p e

A systematic review.

2018 Volume 0206610

Abstract: 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 ... ...

Abstract	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 systematically. OBJECTIVES:To analyse the prevalence and prognosis of new onset organ failure in unselected acute patients at arrival to hospital. METHODS:A systematic review of studies of prevalence and prognosis of acutely ill patients with organ failure at arrival to hospital. We searched PubMed, Cochrane Library, Embase and Cinahl, and read references in included studies. Two authors decided independently on study eligibility and extracted data. Results were summarised qualitatively. RESULTS:Four studies were included with a total of 678,960 patients. The number of different organ failures reported in the studies ranged from one to six, and the settings were emergency departments and wards. The definitions of organ failure varied between studies. The prevalence of organ failure was 7%, 14%, 14%, and 23%, and in-hospital mortality was 5%, 11% and 15% respectively. The relative risk of in-hospital mortality for patients with organ failure compared to patients without organ failure varied from 2.58 to 8.65. Numbers of organ failures per 1,000 visits varied from 71 to 256. CONCLUSION:The results of this review indicate that clinicians have good reasons to be alert when a patient arrives to the emergency department; as a state of organ failure seems both frequent and highly severe. However, most studies identified were performed in patients after a diagnosis was established, and only very few studies were performed in unselected patients. SYSTEMATIC REVIEW REGISTRATION NUMBER:PROSPERO: CRD42017060871.
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2018-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Book ; Online: Observational studies on preventive measures and treatments for Covid-19

Carolina Riveros / Chantal Julia / Astrid Chevance / Fiona Quirke / Isabelle Boutron / Anna Chaimani / Declan Devane / Joerg J Meerpohl / David Tovey / Asbjørn Hróbjartsson / Philippe Ravaud

2020

Abstract: In the course of our PubMed searches and prepreints from MedRxiv, we identified a number of observational studies on preventive measures and treatments for Covid-19 that we have included in our systematic review. This file will be updated regularly. ...

Abstract	In the course of our PubMed searches and prepreints from MedRxiv, we identified a number of observational studies on preventive measures and treatments for Covid-19 that we have included in our systematic review. This file will be updated regularly.
Keywords	Covid-19 ; 2019-nCoV ; SARS-CoV-2 ; covid19
Language	English
Publishing date	2020-05-19
Publishing country	eu
Document type	Book ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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