scholarly journals Association of Appearance of Conflicts of Interest With Voting Behavior at FDA Advisory Committee Meetings—A Cross-sectional Study

2017 ◽  
Vol 177 (7) ◽  
pp. 1038 ◽  
Author(s):  
Jing Xu ◽  
Olubunmi Emenanjo ◽  
Michael Ortwerth ◽  
Peter Lurie
BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e019952 ◽  
Author(s):  
Harriet Ruth Feldman ◽  
Nicholas J DeVito ◽  
Jonathan Mendel ◽  
David E Carroll ◽  
Ben Goldacre

ObjectiveWe set out to document how NHS trusts in the UK record and share disclosures of conflict of interest by their employees.DesignCross-sectional study of responses to a Freedom of Information Act request for Gifts and Hospitality Registers.SettingNHS Trusts (secondary/tertiary care organisations) in England.Participants236 Trusts were contacted, of which 217 responded.Main outcome measuresWe assessed all disclosures for completeness and openness, scoring them for achieving each of five measures of transparency.Results185 Trusts (78%) provided a register. 71 Trusts did not respond within the 28 day time limit required by the FoIA. Most COI registers were incomplete by design, and did not contain the information necessary to assess conflicts of interest. 126/185 (68%) did not record the names of recipients. 47/185 (25%) did not record the cash value of the gift or hospitality. Only 31/185 registers (16%) contained the names of recipients, the names of donors, and the cash amounts received. 18/185 (10%) contained none of: recipient name, donor name, and cash amount. Only 15 Trusts had their disclosure register publicly available online (6%). We generated a transparency index assessing whether each Trust met the following criteria: responded on time; provided a register; had a register with fields identifying donor, recipient, and cash amount; provided a register in a format that allowed further analysis; and had their register publicly available online. Mean attainment was 1.9/5; no NHS trust met all five criteria.ConclusionOverall, recording of employees’ conflicts of interest by NHS trusts is poor. None of the NHS Trusts in England met all transparency criteria. 19 did not respond to our FoIA requests, 51 did not provide a Gifts and Hospitality Register and only 31 of the registers provided contained enough information to assess employees’ conflicts of interest. Despite obligations on healthcare professionals to disclose conflicts of interest, and on organisations to record these, the current system for logging and tracking such disclosures is not functioning adequately. We propose a simple national template for reporting conflicts of interest, modelled on the US ‘Sunshine Act’.


2018 ◽  
Vol 4 (Supplement 1) ◽  
pp. 15s-15s
Author(s):  
Sewunet Admasu Belachew ◽  
Daniel Asfaw Erku ◽  
Abebe Basazn Mekuria ◽  
Begashaw Melaku Gebresillassie

Abstract 32 Purpose Adverse drug reactions (ADRs) are a global problem and constitute a major clinical problem in terms of human suffering. The high toxicity and narrow therapeutic index of chemotherapeutic agents makes oncology pharmacovigilance essential. The objective of the current study was to assess the pattern of ADRs that occur in patients with cancer who were treated with chemotherapy in a tertiary care teaching hospital in Ethiopia. Methods A cross-sectional study over a 2-year period from September 2013 to August 2015 was conducted in patients with cancer who underwent chemotherapy at Gondar University Referral Hospital Oncology Center. Data were collected directly from patients and their medical case files. Reported ADRs were assessed for causality using the WHO causality assessment scale and Naranjo’s algorithm. Severities of the reported reactions were also assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). Pearson’s χ2 test was used to examine the association between two categorical variables. Results A total of 815 ADRs were identified from 203 patients who were included in the study. The most commonly occurring ADRs were nausea and vomiting (18.9%), infections (16.7%), neutropenia (14.7%), fever and/or chills (11.3%), and anemia (9.3%). Platinum compounds (31.4%) were the most common group of drugs that caused ADRs. Of reported ADRs, 65.8% were grades 3 to 4 (severe level), 29.9% were grades 1 to 2 (mild level), and 4.3% were grade 5 (toxic level). Significant association was found between age, number of chemotherapeutic agents, and dose of chemotherapy with the occurrence of grades 3 to 5 toxicity. Conclusion The high incidence of chemotherapy-related ADRs among patients with cancer is of concern. Establishing an effective ADR monitoring and reporting system—oncopharmacovigilance—and creating awareness among health care professionals of the importance of ADR reporting may help prevent the problem. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST No COIs from the authors.


2015 ◽  
Vol 26 (2) ◽  
pp. 148-159 ◽  
Author(s):  
Frank C. Bearden

Conflicts of interest (COI) are an ethical issue for financial planners because they impair professional judgment if not addressed. This article describes a quantitative, cross-sectional study of COI recognition in pending engagements and measuring the influence of time in practice and financial planning credentials upon recognition. Participants were 51 graduates of the M.S. degree from the College for Financial Planning. Participants were asked three questions regarding each of the six hypothetical situations of pending financial planning engagements. Each question provided an indicator of COI recognition. Time in practice and financial planning credentials were used as influence factors upon COI recognition. Results indicated high COI recognition involving role conflict and low recognition with family members as clients. Time in practice was related to increased COI recognition involving role conflict. Financial planning credentials were related to increased COI recognition with a business associate as client.


PLoS ONE ◽  
2016 ◽  
Vol 11 (3) ◽  
pp. e0152301 ◽  
Author(s):  
Khaled Shawwa ◽  
Romy Kallas ◽  
Serge Koujanian ◽  
Arnav Agarwal ◽  
Ignacio Neumann ◽  
...  

BMJ ◽  
2012 ◽  
Vol 345 (aug16 3) ◽  
pp. e5155-e5155 ◽  
Author(s):  
M. Roseman ◽  
E. H. Turner ◽  
J. Lexchin ◽  
J. C. Coyne ◽  
L. A. Bero ◽  
...  

2018 ◽  
Vol 18 (1) ◽  
Author(s):  
Karim N. Daou ◽  
Maram B. Hakoum ◽  
Assem M. Khamis ◽  
Lama Bou-Karroum ◽  
Ahmed Ali ◽  
...  

Iproceedings ◽  
10.2196/35386 ◽  
2021 ◽  
Vol 6 (1) ◽  
pp. e35386
Author(s):  
Erika Kim R Chan ◽  
Jacqueline Michelle D Melendres

Background Telemedicine delivers health care services between two distant locations through the use of information and communication technology. Several medical specializations, such as dermatology, have incorporated telemedicine into their practice. Since dermatologists are trained to diagnose skin, hair, and nail conditions with a clinical eye, teledermatology may be an alternative when a traditional face-to-face clinic visit is not feasible. Objective The purpose of this study was to evaluate the diagnostic reliability of teledermatology. Methods A cross-sectional study was conducted among patients from 2 government hospitals. A total of 39 patients were seen in a face-to-face setting and diagnosed by a consultant dermatologist. A written history of their present illness and accompanying photographs were taken and were shown to 3 consultant teledermatologists, who then diagnosed their condition. Two senior dermatology residents then rated the face-to-face and teledermatology diagnoses as either complete agreement, partial agreement, or no agreement. Descriptive statistics was used to summarize the general and clinical characteristics of the participants. The Cohen kappa was used to assess agreement in the evaluations between the teledermatology and face-to-face diagnoses by senior resident raters #1 and #2. Results Over 70% of the diagnoses were deemed as either partial or in complete agreement with the face-to-face diagnosis for senior resident rater #1. Similarly, over 80% of the diagnoses were deemed as either partial or in complete agreement with the face-to-face diagnosis for senior resident rater #2. The agreement between the ratings of senior residents #1 and #2 ranged from fair to substantial. Conclusions The findings of the study showed that the diagnostic concordance of in-person clinicians and teledermatologists ranges from fair to substantial, with over 70% of the diagnoses in partial or complete agreement. Although face-to-face consultations remain the gold standard, teledermatology is an important alternative where dermatologic care is not accessible. Conflicts of Interest None declared.


2014 ◽  
Vol 108 (3) ◽  
pp. 101-107 ◽  
Author(s):  
Kristine Rasmussen ◽  
Jeppe Schroll ◽  
Peter C Gøtzsche ◽  
Andreas Lundh

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