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Quantification of Conflicts of Interest in an Online Point-of-Care Clinical Support Website.

ABSTRACT: Online medical reference websites are utilized by health care providers to enhance their education and decision making. However, these resources may not adequately reveal pharmaceutical-author interactions and their potential conflicts of interest (CoIs). This investigation: (1) evaluates the correspondence of two well-utilized CoI databases: the Centers for Medicare and Medicaid Services Open Payments (CMSOP) and ProPublica's Dollars for Docs (PDD) and (2) quantifies CoIs among authors of a publicly available point of care clinical support website which is used to inform evidence-based medicine decisions. Two data sources were used: the hundred most common drugs and the top fifty causes of death. These topics were entered into a freely available database. The authors (N = 139) were then input into CMSOP and PDD and compensation and number of payments were determined for 2013-2015. The subset of highly compensated authors that also reported "Nothing to disclose" were further examined. There was a high degree of similarity between CMSOP and PDD for compensation (R² ≥ 0.998) and payment number (R² ≥ 0.992). The amount received was 1.4% higher in CMSOP ($4,059,194) than in PDD ($4,002,891). The articles where the authors had received the greatest compensation were in neurology (Parkinson's Disease = $1,810,032), oncology (Acute Lymphoblastic Leukemia = $616,727), and endocrinology (Type I Diabetes = $377,388). Two authors reporting "Nothing to disclose" received appreciable and potentially relevant compensation. CMSOP and PDD produced almost identical results. CoIs were common among authors but self-reporting may be an inadequate reporting mechanism. Recommendations are offered for improving the CoI transparency of pharmaceutical-author interactions in point-of-care electronic resources.

SUBMITTER: Chopra AC

PROVIDER: S-EPMC7096281 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:From April 2015, NHS England (NHSE) started to devolve responsibility for commissioning primary care services to clinical commissioning groups (CCGs). The aim of this paper is to explore how CCGs are managing potential conflicts of interest associated with groups of GPs commissioning themselves or their practices to provide services.We carried out two telephone surveys using a sample of CCGs. We also used a qualitative case study approach and collected data using interviews and meeting observations in four sites (CCGs).We conducted 57 telephone interviews and 42 face-to-face interviews with general practitioners (GPs) and CCG staff involved in primary care co-commissioning and observed 74 meetings of CCG committees responsible for primary care co-commissioning.Conflicts of interest were seen as an inevitable consequence of CCGs commissioning primary care. Particular problems arose with obtaining unbiased clinical input for new incentive schemes and providing support to GP provider federations. Participants in meetings concerning primary care co-commissioning declared conflicts of interest at the outset of meetings. Different approaches were pursued regarding GPs involvement in subsequent discussions and decisions with inconsistency in the exclusion of GPs from meetings. CCG senior management felt confident that the new governance structures and policies dealt adequately with conflicts of interest, but we found these arrangements face limitations. While the revised NHSE statutory guidance on managing conflicts of interest (2016) was seen as an improvement on the original (2014), there still remained some confusion over various terms and concepts contained therein.Devolving responsibility for primary care co-commissioning to CCGs created a structural conflict of interest. The NHSE statutory guidance should be refined and clarified so that CCGs can properly manage conflicts of interest. Non-clinician members of committees involved in commissioning primary care require training in order to make decisions requiring clinical input in the absence of GPs.

Project description:BackgroundElectronic medical records are widely used in family practices across Canada and can improve health outcomes. However, recent reports indicate that physicians using electronic medical records work longer and have less direct patient contact which may contribute to burnout. Therefore, new and innovative digital tools are essential to reduce physician workloads and improve patient-physician interaction to address physician burnout. The objective of this study was to assess the efficiency and accuracy of clinical decision-making when using a new preventive care point-of-care clinical decision support system (CDSS). An estimate of the potential annual time savings was also determined. This study also assessed physician reported perceived usefulness and ease of use of the CDSS.MethodsQuantitative and qualitative data were collected during this study. Each participant evaluated two simulated patient charts and identified which preventive care metrics were due. The participants recorded their decisions and the time required to assess each chart. Participants then completed a Technology Acceptance Model survey regarding the perceived usefulness and ease of use of the CDSS, which included qualitative feedback. The amount of time saved was determined and participants' clinical decision-making accuracy was scored against current Canadian preventive care guidelines. The number of preventive care specific visits completed per year was determined using clinic billing data.ResultsThe preventive care CDSS saved an average of 195.7 s of chart review time (249.5 s vs 445.2 s; P < 0.001). A total of 1520 preventive visits were performed at Primrose and Bruyère Family Medicine Centres. Extrapolated across the organization, implementation of the new tool could save 82.6 h per year. Decision-making accuracy was not affected by the new tool (78.4% vs 80.9%, P > 0.05). Participants rated the perceived ease of use and usefulness to be very high.ConclusionsNew digital tools may reduce providers' workload without impacting clinical decision-making accuracy. Participants indicated that the preventive care CDSS was useful and easy to use. Further software development and clinical studies are required to further improve and characterize the effect this new CDSS has when implemented in clinical practice.

Project description:BackgroundFinancial conflicts of interest (FCOI) are known to be prevalent in medicine. Authorship of pivotal trials reap non-financial benefits including publication productivity that can be used for assessment of tenure positions and promotion. The purpose of this investigation was to quantify the prevalence and discordance of academic trial author (authors) FCOI in industry-sponsored drug trials that were initially presented as oral abstracts and subsequently resulted in a peer-reviewed publication.MethodsOral abstracts from the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting that were subsequently published were identified. Studies that were non-industry sponsored, non-adult, or non-therapeutic trials were excluded. Studies that did not have a subsequent peer-reviewed publication or had a publication preceding the ASCO 2017 Annual Meeting were also excluded. FCOI was categorized and impact factor (IF) for the journal at the time of publication was retrieved. FCOI discordance between the oral abstract and publication was calculated based on geographic location and IF.ResultsA total of 22 paired abstract and publications met inclusion criteria for further analysis. A total of 384 authors were identified, of these 280 authors (74.1%) were included in both the oral abstract and subsequent publication. A total of 76% of these 280 authors had FCOI and 66.4% had FCOI discordance. There were statistically significant differences for the sum of FCOI discordance for U.S.-based authors (p = 0.0004) but not for journal IF. When analyzing the sum of absolute differences of FCOI discordance, statistical significance was reached for authors from any of the three geographic regions, as well as, low and high IF journals (all p-values < 0.0001).ConclusionsThis study draws attention to the lack of uniformity and vetting of FCOI reporting in abstracts and journals publishing solid tumor oncology trial results. This is particularly concerning, since FCOI is prevalent globally.

Project description:ObjectiveTo 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.DesignQualitative interview study.ParticipantsTrial researchers who had participated in at least 10 clinical trials with methodological or statistical expertise. Researchers differed by geographical location, educational background, and experience with different types of funders. Interviewees were identified by searches on Web of Science and snowball sampling. 52 trial researchers were approached by email; 20 agreed to be interviewed.SettingInterviews conducted by telephone, recorded, transcribed verbatim, imported to NVivo 12, and analysed by systematic text condensation. Semistructured interviews focused on financial and non-financial conflicts of interest.ResultsThe interviewees had participated in a median of 37.5 trials and were mainly male physicians who had experience with commercial and non-commercial trial funders. Two predefined themes (influence of conflicts of interest and management strategies) and two additional themes (definition and reporting of conflicts of interest) emerged. Examples of perceived influence of conflicts of interest were: choice of inferior comparator, manipulation of the randomisation process, prematurely stopping the trials, fabrication of data, blocking access to data, and spin (eg, overly favourable interpretation of the results). Examples of strategies to manage conflicts of interest were: disclosure procedures, exclusion of the funder from design and analysis, independent committees, contracts ensuring complete access to the data, and no restriction by the funder on analysis and reporting. Interviewees used different definitions or thresholds for what they considered to be conflicts of interest, and they described different criteria for when to report them. Some interviewees considered non-commercial financial conflicts of interest (eg, funding of trials by governmental health agencies with a political agenda) to be equally or more important than commercial financial conflicts of interest (eg, funding by drug and device companies), but more challenging to report and manage.ConclusionThis study described how trial researchers perceive conflicts of interest unduly influencing clinical trials they had worked on, and the management strategies they used to prevent these influences. The results indicated considerable variability in researchers' understanding of what conflicts of interest are and when they should be reported.

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Quantification of Conflicts of Interest in an Online Point-of-Care Clinical Support Website.

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