Association of author’s financial conflict of interest with characteristics and outcome of rheumatoid arthritis randomized controlled trials

Abstract Objective To examine the prevalence, types and temporal trends of reported financial conflicts of interest (FCOIs) among authors of drug therapy randomized controlled trials (RCTs) for RA and their association with study outcomes. Methods We identified original, non–phase 1, parallel-group, drug therapy RA RCTs published in the years 2002–03, 2006–07, and 2010–11. Two investigators independently obtained trial characteristics data. Authors’ FCOIs were classified as honoraria/consultation fees receipt, employee status, research grant, and stock ownership. Multivariable logistic regression was performed to identify whether FCOIs were independently associated with study outcome. Results A total of 146 eligible RCTs were identified. Of these, 83 (58.4%) RCTs had at least one author with an FCOI [employee status: 63 (43.2%), honoraria/consultation fees receipt: 49 (33.6%), research grant: 30 (20.5%), and stock ownership: 28 (19.2%)]. A remarkable temporal increase in reporting of honoraria/consultation fees receipt, research grant, and stock ownership was seen. The reporting of any FCOI itself was not associated with positive outcome [50/73 (68.5%) with author FCOI vs 36/52 (69.2%) without author FCOI, P = 0.93]. However, honoraria/consulting fees receipt was independently associated with increased likelihood of a positive outcome [adjusted odds ratio (95% CI) of 3.24 (1.06–9.88)]. In general, trials with FCOIs were significantly more likely to be multicentre, have larger enrolment, use biologic or a small molecule as the experimental intervention, and have better reporting of some methodological quality measures. Conclusion FCOI reporting in RA drug RCT authors is common and temporally increasing. Receipt of honoraria/consulting fees was independently associated with a positive study outcome.

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Financial conflicts of interest and their association with outcome and quality of fibromyalgia drug therapy randomized controlled trials

International Journal of Rheumatic Diseases ◽

10.1111/1756-185x.12607 ◽

2015 ◽

Vol 18 (6) ◽

pp. 606-615 ◽

Cited By ~ 11

Author(s):

Winnie K. Pang ◽

Karen C. Yeter ◽

Karina D. Torralba ◽

Horace J. Spencer ◽

Nasim A. Khan

Keyword(s):

Drug Therapy ◽

Randomized Controlled Trials ◽

Conflicts Of Interest ◽

Controlled Trials ◽

Randomized Controlled ◽

Financial Conflicts Of Interest

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Absence of a positive outcome bias in randomized controlled trials of minimally invasive surgical techniques

Journal of Clinical Epidemiology ◽

10.1016/j.jclinepi.2020.11.022 ◽

2020 ◽

Author(s):

Rashid K. Sayyid ◽

Soum D. Lokeshwar ◽

David Tella ◽

Caitlin E. Jones ◽

Zachary Klaassen ◽

...

Keyword(s):

Minimally Invasive ◽

Randomized Controlled Trials ◽

Surgical Techniques ◽

Positive Outcome ◽

Controlled Trials ◽

Randomized Controlled ◽

Minimally Invasive Surgical ◽

Outcome Bias

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What interventions should we add to weight reducing diets in adults with obesity? A systematic review of randomized controlled trials of adding drug therapy, exercise, behaviour therapy or combinations of these interventions

Journal of Human Nutrition and Dietetics ◽

10.1111/j.1365-277x.2004.00530.x ◽

2004 ◽

Vol 17 (4) ◽

pp. 293-316 ◽

Cited By ~ 107

Author(s):

A. Avenell ◽

T. J. Brown ◽

M. A. McGee ◽

M. K. Campbell ◽

A. M. Grant ◽

...

Keyword(s):

Systematic Review ◽

Drug Therapy ◽

Randomized Controlled Trials ◽

Controlled Trials ◽

Behaviour Therapy ◽

Randomized Controlled ◽

Exercise Behaviour

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Can musical intervention improve memory in Alzheimer’s patients? Evidence from a systematic review

Dementia & Neuropsychologia ◽

10.1590/1980-57642018dn12-020005 ◽

2018 ◽

Vol 12 (2) ◽

pp. 133-142 ◽

Cited By ~ 7

Author(s):

Shirlene Vianna Moreira ◽

Francis Ricardo dos Reis Justi ◽

Marcos Moreira

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Randomized Trials ◽

Positive Outcome ◽

Memory Deficit ◽

Cochrane Library ◽

Controlled Trials ◽

Exclusion Criteria ◽

Randomized Controlled

ABSTRACT Treatment with music has shown effectiveness in the treatment of general behavioural and cognitive symptoms of patients with various types of dementia. Objective: To assess the effectiveness of treatment with music on the memory of patients with Alzheimer’s disease (AD). Methods: A systematic search was performed on PubMed (Medline), Cochrane Library, PsycINFO and Lilacs databases up to June 2017 and included all randomized controlled trials that assessed memory using musical interventions in patients with AD. Results: Forty-two studies were identified, and 24 studies were selected. After applying the exclusion criteria, four studies involving 179 patients were included. These studies showed the benefits of using music to treat memory deficit in patients with AD. Conclusion: To the best of our knowledge, this is the first systematic review focusing on randomized trials found in the literature that analysed the role of musical interventions specifically in the memory of patients with AD. Despite the positive outcome of this review, the available evidence remains inconsistent due to the small number of randomized controlled trials.

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Precisely Equal Group Size and Allocation Bias in Nursing Randomized Controlled Trials: A Scientiometric Study

10.20944/preprints202107.0316.v1 ◽

2021 ◽

Author(s):

Richard Gray ◽

Daniel Bressington ◽

Martin Jones ◽

David R. Thompson

Keyword(s):

Randomized Controlled Trials ◽

Sample Size ◽

Group Size ◽

Sample Size Calculation ◽

Positive Outcome ◽

Outcome Data ◽

Controlled Trials ◽

Nursing Science ◽

Equal Group ◽

Randomized Controlled

The manipulation of participant allocation in randomized controlled trials to achieve equal groups sizes may introduce allocation bias potentially leading to larger treatment effect estimates. This study aimed to estimate the proportion of nursing trials that have precisely equal group sizes and examine if there was an association with trial outcome. Data were extracted from a sample of 148 randomized controlled trials published in nursing science journals in 2017. One hundred trials (68%) had precisely equal group sizes. Respectively, a positive outcome was reported in 70% and 58% of trials with equal/unequal groups. Trials from Asia were more likely to have equal group sizes than those from the rest of the world. Most trials reported a sample size calculation (n=105, 71%). In a third of trials (n=36, 34%), the number of participants recruited precisely matched the requirement of the sample size calculation; this was significantly more common in studies with equal group sizes. The high number of nursing trials with equal groups may suggest nurses con-ducting clinical trials are manipulating participant allocation to ensure equal group size increasing the risk of bias.

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Critical and Comprehensive Ethical Analysis on Pragmatic Randomized Controlled Trials

10.31124/advance.12401960.v1 ◽

2020 ◽

Author(s):

Soaad Hossain

Keyword(s):

Medical Ethics ◽

Randomized Controlled Trials ◽

Ethical Issues ◽

Conflicts Of Interest ◽

Ethical Analysis ◽

Ethical Framework ◽

Controlled Trials ◽

Research Practice ◽

Randomized Controlled ◽

Regulatory Frameworks

The interest of pragmatic randomized controlled trials continues to increase as they are much better suited for studies of how to get medical and health services out into wider practice. However, despite the advantage that such trials have, there are several ethical issues and medical ethics issues that persist with the trial. The ethical and medical ethics issues involve research-practice distinction, consent, disclosure, vulnerable populations, oversight, ethical principles, ethical framework, regulatory frameworks, and conflicts of interest. Through performing an elaborate literature review and analyzing claims and arguments made within the literature, we will provide a critical and comprehensive ethical analysis on pragmatic randomized controlled trials, and we will begin the discussion on conflicts of interest in pragmatic RCTs, arguing that conflicts of interest occur in pragmatic RCTs.

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The randomised controlled trial in medical research: using bibliometric methods to identify core journals

Evidence Based Library and Information Practice ◽

10.18438/b8cc7m ◽

2006 ◽

Vol 1 (1) ◽

pp. 104

Author(s):

John Loy

Keyword(s):

Growth Rate ◽

Drug Therapy ◽

Randomized Controlled Trials ◽

Detailed Analysis ◽

Medical Literature ◽

Controlled Trial ◽

The United States ◽

Growth Patterns ◽

Controlled Trials ◽

Randomized Controlled

A review of: Tsay, Migh-yueh, and Yen-hsu Yang. “Bibliometric Analysis of the Literature of Randomized Controlled Trials.” Journal of the Medical Library Association 93.4 (October 2005): 450-58. Objective – To explore the characteristics and distribution of randomized controlled trials (RCTs) in the medical literature. The study aims to identify the growth patterns of the RCT, key subject matter, country and language of publication, and determine a list of core journals which contain a substantial proportion of the RCT literature. Design – Retrospective analysis of RCTs. Setting – Medical journal literature. Subjects – A total of 160,213 articles published between 1965-2001. Detailed analysis of a subset numbering 114,850 articles published from 1990-2001. Methods – The study seeks to identify all RCTs in MEDLINE from 1965-2001, and examines the growth rate of the RCT. The authors then do a more detailed analysis on a subset of data from 1990-2001, using Access database and Excel spreadsheet software, and PERL programming language. The references were analyzed by five fields within MEDLINE; publication type, source, language, country of publication, and descriptor (subject index). Main results – An exponential growth rate for the RCT is demonstrated, suggesting that in the medical literature development has not yet matured and that research using this method continues to grow. A growth rate for the RCT of 11.2% per annum is identified. The most common form of publication is the journal article, making up approximately 98% of the RCT literature. Approximately 75% of the RCTs are multicentre trials indicating that this is the design of choice adopted by researchers. The United States proves to be the greatest source of RCT literature, with 39.9% of journals and 50.6% of articles originating there. After the USA, the most productive countries are England (15.8% of journals and 21.7% articles) and Germany (6.5% journals and 6.1% articles). As might be expected, English is the predominant language providing 92.9% of the total publications. Of the remaining 7%, German is the most common language accounting for 2.2%. The top three areas being researched are: 1. Drug therapy for hypertension - 2291 citations 2. Anticancer drug combinations - 2140 citations 3. Drug therapy and asthma - 1397 citations Bradford’s law of scattering is successfully applied, identifying four zones of journals which each publish approximately 26,000 articles. Conclusion – The results indicate that bibliometric methods can be applied to the medical literature, and highlight those disciplines in which RCTs more often occur. A core list of 42 journal titles is presented, providing busy practitioners with invaluable guidance as to which journals are most likely to publish the greater number of RCTs.

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