Disclose Funding Sources Research Articles

Failure to disclose industry funding impacts outcomes in randomized controlled trials of platelet-rich plasma.

Platelet-rich plasma (PRP) represents a highly profitable biological therapy. Platelet-rich plasma is widely used to treat musculoskeletal disorders despite mixed evidence of its efficacy. As evidenced by literature from other domains, industry funding may influence the results of clinical trials. The objective of the current study was to determine the association between industry funding and positive results for randomized controlled trials (RCTs) assessing the efficacy of PRP in musculoskeletal disorders. A search of four databases was conducted. Included studies were RCTs comparing PRP to any non-PRP comparator in adults (18years old or over) with musculoskeletal disorders and had full text available in English. Studies were excluded if they were published before 2016 or were non-human trials. A multivariate binomial logistic regression model was created to explore predictors of statistically significant findings. Covariates included the presence of industry funding, sample size, and length of study follow-up. 1440 records were screened with 87 trials included in the final analysis. Of the 87 studies, 61 (70%) reported a statistically significant primary outcome. The presence of industry funding was not predictive of a statistically significant primary outcome [OR = 0.36, 95% CI 0.096-1.36, (n.s.)]. Studies that did not state whether industry funding was present had a higher chance of reporting a statistically significant primary outcome (OR = 3.61, 95% CI 1.1-11.9, p = 0.035). Sample size and length of follow-up were not predictive of a statistically significant primary outcome. The results of the current study conclude that industry funding had no impact on the reporting of positive results for RCTs investigating PRP in musculoskeletal disorders. However, not disclosing sources of funding was associated with a higher likelihood of reporting positive results. The results of trials that fail to disclose funding sources should be interpreted with caution in the PRP literature. I.

Quality Assessment of Modern Total Ankle Arthroplasty Clinical Outcomes Research

Research demonstrating improved outcomes with third-generation ankle replacement implants has resulted in increasing utilization of total ankle arthroplasty over the past 3 decades. The purpose of this study was to examine the quality and trends of clinical outcomes research being published on third-generation total ankle arthroplasty implants. Two fellowship-trained foot and ankle surgeons reviewed all peer-reviewed, Medline-indexed English-language clinical outcomes studies evaluating total ankle arthroplasty published between 2006 and 2019. Articles were assessed for study design and indicators of study quality. A total of 694 published articles were reviewed and 231 met all inclusion criteria. The majority (78%) of studies were retrospective, most of which were case series (54%) or cohorts (32%). Ten percent (10%) of studies were funded by industry and 28% did not disclose funding sources. Thirty-eight percent (38%) of studies reported a conflict of interest and 6% did not disclose whether or not there were conflicts. The average patient follow-up time across studies was 72 months. We found that although the study of outcomes with third-generation total ankle arthroplasty prostheses is steadily increasing, most studies are Level IV, retrospective case series. Some studies have disclosed industry funding and/or a conflict of interest, and a considerable number did not disclose potential funding and/or financial conflicts. Future investigators should strive to design studies with the highest quality methodology possible.

Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age.

Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age.

Reporting of financial conflicts of interest by Canadian clinical practice guideline producers: a descriptive study.

The producers of clinical practice guidelines (CPGs) may not disclose industry funding in their CPGs. We reviewed Canadian national CPGs to examine the existence and disclosure of industry-related organizational funding in the CPGs, financial conflicts of interest of committee members and organizational procedures for managing financial conflicts of interest. For this descriptive study, we searched the asset map of the Strategy for Patient-Oriented Research Evidence Alliance and the CPG Infobase for CPGs published between Jan. 1, 2016, and Nov. 30, 2018. Eligible guidelines had to have a national focus and either a first-line drug recommendation or a screening recommendation leading to drug treatment. One investigator reviewed all CPG titles to exclude those that were clearly ineligible. Two reviewers independently reviewed all remaining guidelines and extracted data. We analyzed the data descriptively. We included 21 CPGs: 3 from government-sponsored organizations, 9 from disease or condition interest groups and 9 from medical professional societies. None of the 3 government-sponsored organizations reported industry funding, and none of their committee members disclosed financial conflicts of interest. Among the 18 disease or condition interest groups and medical professional societies, 14 (93%) of the 15 that disclosed funding sources on websites (3 did not disclose) reported organizational funding from industry, but none disclosed this information in the CPGs; 12 (86%) of the 14 with conflict-of-interest disclosure statements in the CPG (4 did not include disclosures) had at least 1 committee member with a financial conflict (mean proportion of committee members with a conflict 56%); and for all 8 CPGs with identifiable chairs or cochairs (chairs or cochairs not reported for 10) at least 1 of these people had a financial conflict of interest. None of the guidelines described a plan to manage organizational financial conflicts of interest. Canadian CPGs are vulnerable to industry influence through funding of producers of guidelines and through the financial conflicts of interest of committee members. The CPG producers that receive industry funding should disclose organizational financial conflicts in the CPGs, should engage independent oversight committees and should restrict voting on recommendations to guideline panelists who have no financial conflicts.

An empirical assessment of transparency and reproducibility-related research practices in the social sciences (2014-2017).

Serious concerns about research quality have catalysed a number of reform initiatives intended to improve transparency and reproducibility and thus facilitate self-correction, increase efficiency and enhance research credibility. Meta-research has evaluated the merits of some individual initiatives; however, this may not capture broader trends reflecting the cumulative contribution of these efforts. In this study, we manually examined a random sample of 250 articles in order to estimate the prevalence of a range of transparency and reproducibility-related indicators in the social sciences literature published between 2014 and 2017. Few articles indicated availability of materials (16/151, 11% [95% confidence interval, 7% to 16%]), protocols (0/156, 0% [0% to 1%]), raw data (11/156, 7% [2% to 13%]) or analysis scripts (2/156, 1% [0% to 3%]), and no studies were pre-registered (0/156, 0% [0% to 1%]). Some articles explicitly disclosed funding sources (or lack of; 74/236, 31% [25% to 37%]) and some declared no conflicts of interest (36/236, 15% [11% to 20%]). Replication studies were rare (2/156, 1% [0% to 3%]). Few studies were included in evidence synthesis via systematic review (17/151, 11% [7% to 16%]) or meta-analysis (2/151, 1% [0% to 3%]). Less than half the articles were publicly available (101/250, 40% [34% to 47%]). Minimal adoption of transparency and reproducibility-related research practices could be undermining the credibility and efficiency of social science research. The present study establishes a baseline that can be revisited in the future to assess progress.

Methodological quality of clinical practice guidelines for nutrition and weight gain during pregnancy: a systematic review.

Ensuring a healthy pregnancy and achieving optimal gestational weight gain (GWG) are important for maternal and child health. Nevertheless, the nutritional advice provided during pregnancy is often conflicting, suggesting limited adherence to clinical practice guidelines (CPGs). The aim of this review was to identify all CPGs on maternal nutrition and GWG and to critically appraise their methodological quality. The MEDLINE/PubMed, Cochrane, Guidelines International Network, and BMJ Best Practice databases, along with gray literature, were searched from inception until February 2019 for CPGs and consensus, position, and practice papers. Clinical practice guidelines published in English and containing advice on maternal nutrition or GWG were eligible. Two authors independently extracted data on items pertaining to maternal nutrition or GWG, and CPGs were appraised using the AGREEII instrument. Twenty-two CPGs were included. All scored adequately in the "scope" domain, but most were considered inadequate with regard to stakeholder involvement, rigor of development, applicability, and editorial independence. Many CPGs lacked patient or dietician involvement, and more than half did not disclose funding sources or conflicts of interest. Guidance on GWG was based mostly on Institute of Medicine thresholds, while nutrition recommendations appeared scattered and heterogeneous. Despite the importance of maternal nutrition and the plethora of advising bodies publishing relevant guidance, there is room for substantial improvement in terms of development standards and content of nutritional recommendations. PROSPERO registration number CRD42019120898.

Gambling Research and Funding Biases.

A recent systematic review of the responsible gambling research suggests that there are no significant differences between gambling industry and non-industry funded research with regard to research design and outcomes. This study empirically synthesizes the outcomes of a larger sample of the scientific gambling literature to determine the generalizability of these original results. Our goal was to determine the extent to which funding sources might differentially influence characteristics of research design and outcomes. We conducted a comprehensive review of 18 research databases and examined studies published between January 2008 and August 2018. For four gambling-related journals, we reviewed all of the available studies. For 14 addiction-related journals, we examined only studies that examined gambling-related outcomes. To be included in this study, publications had to be quantitative and include a clear gambling-related hypothesis. After retrieving 1731 gambling studies, we applied the inclusion criteria and retained 720 studies for our final analytic sample. We used hypothesis confirmation and funding source information to determine the presence or absence of funding bias. Gambling industry funded studies were no more likely than studies not funded by the gambling industry to report either confirmed, partially confirmed, or rejected hypotheses. Nonetheless, studies funded by the gambling industry were more likely than other types of funding sources to include a conflict of interest statement. Studies with disclosed funding sources were more likely than those with undisclosed funding sources to include a conflict of interest statement. These findings highlight the importance of transparency and disclosure during research dissemination.

Funding sources and outcomes of dairy consumption research – A meta-analysis of cohort studies: The case of type-2 diabetes and cardiovascular diseases

Despite requirements to disclose funding sources and contributors involved with published research, industry-funded research is frequently viewed as inherently biased. A meta-analysis (29 cohort studies) was conducted to investigate the association between dairy consumption and the risk of type-2 diabetes (T2D) and cardiovascular diseases (CVD), comparing findings from industry-funded versus non-industry-funded research. Pooled results indicated an inverse association between dairy intake and the risk of T2D and CVD (RR = 0.923; 95% CI: 0.884–0.964; p < 0.001). Studies funded by neutral organisations (21) indicated that dairy consumption is significantly associated with decreased risk of developing T2D and CVD (RR = 0.920; 95% CI: 0.875–0.967; p < 0.01), whereas for studies funded by the food industry (8), the results were not significant (RR = 0.932; 95% CI: 0.854–1.017; p = 0.115). Subgroup analysis showed that there were no significant differences between industry-funded and neutral, non-industry-funded research studies.

The relationship of study and authorship characteristics on trial sponsorship and self-reported conflicts of interest among neuro-oncology clinical trials.

To examine the association between trial sponsorship sources, self-reported conflicts of interest (COI), and study and author characteristics in central nervous system (CNS) oncology clinical trials (CT). MEDLINE search was performed for original CT on "Central Nervous System Neoplasms"[Mesh]. The investigators assessed for relationships between funding source (industry, academic or cooperative, none, not described), COI (presented, none, or not reported), CT, and author characteristics. From 2010 to 2015, 319 CT were considered eligible. The majority of the studies involved primary gliomas (55.2%) and were Phase II CT (59.2%). Drug therapy was investigated in 83.0% of the CT. The remaining studies investigated surgery or radiotherapy. A minority of papers were published in journals with impact factor (IF) higher than > 10 (16%) or in regions other than North America and Europe (20.4%). Overall, 83.1% of studies disclosed funding sources: 32.6% from industry alone, 33.9% from an academic or cooperative group, and 10.7% from a mixed funding model. COI data was reported by 85.9% of trials, of which 56.2% reported no COI and 43.8% reported a related COI. Significant predictors for sponsorship (industry and/or academia) on univariate analysis were study design, type of intervention, journal impact factor, study conclusion, transparency of COI and presence of COI. On multivariate analysis, type of intervention, (P < 0.001), journal impact factor (IF) (P = 0.003), presence of COI (P < 0.001) and study conclusion (P = 0.003) remained significant predictors of sponsorship. For predicting COI, significant variables on univariate analysis were disease type, type of intervention, journal IF, funding source, and intervention arm being related to sponsor. On multivariate analysis, disease type (P = 0.003), journal IF (P < 0.001), type of intervention (P = 0.001), and funding source (P = 0.008) remained significant. The majority of CNS CT reported some external funding sources and non-related COI. We identified that drug trials, higher IF, presence of COI, and a neutral or negative study conclusion are associated with external funding. Likewise drug trials, higher IF, and glioma trials are associated with presence of COI.

Climate skeptic under investigation for allegedly failing to disclose funding sources

Climate skeptic under investigation for allegedly failing to disclose funding sources

Conflicts of interest and critiques of the use of systematic reviews in policymaking: an analysis of opinion articles.

BackgroundStrong opinions for or against the use of systematic reviews to inform policymaking have been published in the medical literature. The purpose of this paper was to examine whether funding sources and author financial conflicts of interest were associated with whether an opinion article was supportive or critical of the use of systematic reviews for policymaking. We examined the nature of the arguments within each article, the types of disclosures present, and whether these articles are being cited in the academic literature.MethodsWe searched for articles that expressed opinions about the use of systematic reviews for policymaking. We included articles that presented opinions about the use of systematic reviews for policymaking and categorized each article as supportive or critical of such use. We extracted all arguments regarding the use of systematic reviews from each article and inductively coded each as internal or external validity argument, categorized disclosed funding sources, conflicts of interest, and article types, and systematically searched for undisclosed financial ties. We counted the number of times each article has been cited in the “Web of Science.” We report descriptive statistics.ResultsArticles that were critical of the use of systematic reviews (n = 25) for policymaking had disclosed or undisclosed industry ties 2.3 times more often than articles that were supportive of the use (n = 34). We found that editorials, comments, letters, and perspectives lacked published disclosures nearly twice as often (60% v. 33%) as other types of articles. We also found that editorials, comments, letters, and perspectives were less frequently cited in the academic literature than other article types (median number of citations = 5 v. 19).ConclusionsIt is important to consider whether an article has industry ties when evaluating the strength of the argument for or against the use of systematic reviews for policymaking. We found that journal conflict of interest disclosures are often inadequate, particularly for editorials, comments, letters, and perspectives and that these articles are being cited as evidence in the academic literature. Our results further suggest the need for more consistent and complete disclosure for all article types.

Disclosure of funding sources and conflicts of interest in phase III surgical trials: survey of ten general surgery journals.

Discussions regarding disclosure of funding sources and conflicts of interest (COI) in published peer-reviewed journal articles are becoming increasingly more common and intense. The aim of the present study was to examine whether randomized controlled trials (RCTs) published in leading surgery journals report funding sources and COI. All articles reporting randomized controlled phase III trials published January 2005 through December 2010 were chosen for review from ten international journals. We evaluated the number of disclosed funding sources and COI, and the factors associated with such disclosures. From a review of 657 RCT from the ten journals, we discovered that presence or absence of a funding source and COI was disclosed by 47 % (309) and 25.1 % (165), respectively. Most articles in "International Committee of Medical Journal Editors (ICMJE)-affiliated journals" did not disclose COI. Disclosure of funding was associated with a journal impact factor >3 (51.7 vs 41.6 %; p < 0.01), statistician/epidemiologist involvement (64.2 vs 43.7 %; p < 0.001), publication after 2008 (52.9 vs 41.1 %; p < 0.01), and the journal being ICMJE-affiliated (49.3 vs 40 %; p < 0.05). Conflict of interest disclosure was associated with publication after 2008 (38.7 vs 11.3 %; p < 0.001), and with the journal not being affiliated with ICMJE (36.9 vs 21.3 %; p < 0.001). Of the published studies we investigated, over half did not disclose funding sources (i.e., whether or not there was a funding source), and almost three quarters did not disclose whether COI existed. Our findings suggest the need to adopt best current practices regarding disclosure of competing interests to fulfill responsibilities to readers and, ultimately, to patients.

Nutrition for critically ill patients

Nutrition is an integral component of general care for critically ill patients, and numerous randomized trials have addressed research questions related to the optimal feeding route, formulation, dose, and timing of initiation. The mission of the free website http://www.criticalcarenutrition.com is 'to improve the practice of nutrition support in the critical care setting through knowledge translation', with specific objectives for knowledge generation, synthesis and translation. Most of the website's resources are devoted to the dissemination of a recently published multidisciplinary evidence-based clinical practice guideline (CPG) on nutritional support for mechanically ventilated critically ill adults [1]. The guideline was peer funded and developed with the participation of multiple academic, professional society, and industry stakeholders. The related website is operated by Critical Care Nutrition, a group of Canadian intensivists and dietitians with diverse backgrounds (intensive care, surgery, nutrition, clinical epidemiology). For practicing clinicians, including intensive care unit (ICU) directors and dietitians, the most useful website features are the Tools & Training Kit (designed to facilitate local CPG implementation) and the Nutrition Survey. Implementation tools include a training manual (text and flow diagrams that highlight important CPG recommendations), sample order sets for glycemic control and enteral feeding, printable summary pocket cards, and tips on organizing an implementation workshop. Nine slide presentations on various nutrition topics (e.g. 'Optimizing the Benefits and Minimizing the Risk of Enteral Nutrition' and 'Nutritional Support in Severe Acute Pancreatitis') are available as zipped PowerPoint files and can be modified for local use. Overall, the materials are comprehensive, practical, and novel. They are especially appealing given the traditional ineffective approach of relying on journal publication as the primary method of knowledge translation. However, an enthusiastic but administratively inexperienced intensivist or dietitian may find it extremely challenging to build a nutritional quality improvement program using the website tools. Additional useful information would include the following: a specific 'how-to' manual for implementing the CPG (which might include a downloadable lecture, a sample project timeline, and estimated personnel, time and monetary requirements); links to general change management resources; and evidence of usability testing of the implementation tools to match the rigor of the CPG development process. The Nutrition Survey is a quality improvement tool that an ICU can use initially to compare its nutrition practice to that in other centres and subsequently to assess the impact of a quality improvement initiative on adherence to best practices. Patient data are entered on the website either directly or after initial data entry on downloadable printable forms. Local experience with the survey has been positive, with straightforward, rapid, and reliable web data entry. The ICU must enter data on at least 10 patients in order to receive a report. Prospective participants can examine the manual data collection forms and help information, but there is no information on the length of time required for data entry, sample reports, or the number and experience of participating hospitals to date. Other useful features of the site are a list of planned and ongoing nutritional support studies initiated by the Critical Care Nutrition group and a list of upcoming conferences (although at the time of this review the three conferences listed had already taken place). Of note, one recently completed randomized trial evaluated the effectiveness of the website's implementation tools as compared with passive CPG dissemination. The website is functional, with rapid page loading and downloads, easy navigation, working links to nutrition and critical care professional organizations, and no advertisements. I saved some files to my hard drive because they would not open directly. The website does not disclose funding sources but it does not endorse or advertise specific products. There are plans to update the CPG as new evidence becomes available. Other objectives, such as developing a warehouse of randomized trials of nutritional interventions, remain to be implemented. Overall, this site provides intensivists, dietitians, and others interested in nutritional support of the critically ill with a rich set of tools to help translate evidence-based recommendations into practice.