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Biedermann BM, Fathi A, Kotlier JL, Lamb CJ, Ahmad A, Bolia IK, Mayfield C, Petrigliano FA, Liu JN. Results of Randomized Controlled Trials of Platelet-Rich Plasma in Lower-Extremity Tendinopathy Are Not Influenced by Industry Sponsorship. Arthroscopy 2025; 41:848-856. [PMID: 38703920 DOI: 10.1016/j.arthro.2024.04.015] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/28/2024] [Revised: 03/22/2024] [Accepted: 04/02/2024] [Indexed: 05/06/2024]
Abstract
PURPOSE To determine whether industry affiliation influences the results of randomized controlled trials (RCTs) studying the use of platelet-rich plasma (PRP) for the treatment of patellar or Achilles tendinopathy. METHODS The PubMed, Scopus, Cochrane, and MEDLINE databases were searched in July 2023 for RCTs investigating PRP for the treatment of patellar or Achilles tendinopathy published between 2009 and July 2023. Industry affiliation was determined by analyzing each study's funding or conflict-of-interest section. Author disclosures were searched in the American Academy of Orthopaedic Surgeons disclosure database and the Centers for Medicare & Medicaid Services open payments database. An industry-affiliated (IA) designation was given if an author had a relevant disclosure or if the company that funded the study manufactured PRP. Otherwise, a non-industry-affiliated (NIA) designation was given. Fisher exact analysis was used to determine whether PRP had a favorable effect, no significant effect, or an unfavorable effect on outcome. RESULTS Analysis was performed on 22 studies (10 IA and 12 NIA), with 17 studies (77.3%) reporting a conflict of interest or funding for the research, 4 (18.2%) reporting no conflict of interest, and 1 (4.5%) with no reporting. Of the 22 included studies, 8 (36.4%) reported favorable outcomes regarding PRP use and 14 (63.6%) reported no significant effect. Favorable outcomes were found in 4 of the 10 IA studies (40.0%), whereas no significant effect was reported in 6 (60.0%). The 12 NIA studies included 4 (33.3%) with favorable results and 8 (66.7%) with no significant effect. The comparison between industry affiliation and results reported was not statistically significant (P > .999). CONCLUSIONS The results of RCTs evaluating the use of PRP in lower-extremity tendinopathy were not influenced by industry sponsorship. CLINICAL RELEVANCE Most biomedical research is funded through industry sponsorship. Although this relation is necessary as technologies are developed, it is important to scrutinize studies for evidence of industry bias to understand how this bias may be affecting study results published in the literature.
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Affiliation(s)
- Brett M Biedermann
- Keck School of Medicine, University of Southern California, Los Angeles, California, U.S.A..
| | - Amir Fathi
- Keck School of Medicine, University of Southern California, Los Angeles, California, U.S.A
| | - Jacob L Kotlier
- Keck School of Medicine, University of Southern California, Los Angeles, California, U.S.A
| | - Chris J Lamb
- Keck School of Medicine, University of Southern California, Los Angeles, California, U.S.A
| | - Aamir Ahmad
- Keck School of Medicine, University of Southern California, Los Angeles, California, U.S.A
| | - Ioanna K Bolia
- Keck School of Medicine, University of Southern California, Los Angeles, California, U.S.A
| | - Cory Mayfield
- Keck School of Medicine, University of Southern California, Los Angeles, California, U.S.A
| | - Frank A Petrigliano
- Keck School of Medicine, University of Southern California, Los Angeles, California, U.S.A
| | - Joseph N Liu
- Keck School of Medicine, University of Southern California, Los Angeles, California, U.S.A
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Major RM, Davis AM, Henderson GE, Inamine G, Conley JM. The public-private research ecosystem in the genome editing era. iScience 2024; 27:109896. [PMID: 38784021 PMCID: PMC11112366 DOI: 10.1016/j.isci.2024.109896] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/07/2023] [Revised: 02/27/2024] [Accepted: 05/01/2024] [Indexed: 05/25/2024] Open
Abstract
Biomedical research in the US has long been conducted in a public-private (PP) "ecosystem." Today, especially with gene therapies and genome editing-based medicine, publicly funded researchers frequently hand off their research to the private sector for clinical development, often to small, venture capital-funded startups in which they have a financial interest. This trend raises ethical questions about conflicts of interest, effectiveness of regulatory oversight, and justice in therapy access, that we are addressing in a multi-year, multidisciplinary study of the evolving governance of genome editing. This paper draws on interviews with scientists working across the PP divide and their private sector business and financial partners. We find little concern about potential ethical dilemmas, with two exceptions expressed by public sector scientists: concerns about inequitable access to treatments due to disparities in wealth, ethnicity, and health insurance benefits; and about whether their private collaborators' profit motive may affect their research objectives.
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Affiliation(s)
- Rami M. Major
- Curriculum in Genetics and Molecular Biology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
| | - Arlene M. Davis
- Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
| | - Gail E. Henderson
- Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
| | - Greg Inamine
- University of North Carolina School of Law, University of North Carolina at Chapel Hill, Chapel Hill, NC USA
| | - John M. Conley
- University of North Carolina School of Law, University of North Carolina at Chapel Hill, Chapel Hill, NC USA
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3
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Binko MA, Reitz KM, Chaer RA, Haga LM, Go C, Alie-Cusson FS, Tzeng E, Eslami MH, Sridharan ND. Selective Publication within Vascular Surgery: Characteristics of Discontinued and Unpublished Randomized Clinical Trials. Ann Vasc Surg 2023; 95:251-261. [PMID: 37311508 DOI: 10.1016/j.avsg.2023.05.035] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/13/2023] [Revised: 05/25/2023] [Accepted: 05/31/2023] [Indexed: 06/15/2023]
Abstract
BACKGROUND Discontinued and unpublished randomized clinical trials (RCTs) are common resulting in biased publication and loss of potential knowledge. The magnitude of selective publication within vascular surgery remains unknown. METHODS RCT relevant to vascular surgery registered (01/01/2010-10/31/2019) on ClinicalTrials.gov were included. Trials ending normally with conclusion of participant treatment and examination were considered completed whereas discontinued trials stopped early. Publications were identified through automatically indexed PubMed citations on ClinicalTrials.gov or manually identified on PubMed or Google Scholar >30 months after the completion date, the date the final participant was examined, allowing time for publication. RESULTS Of 108 RCT (n = 37, 837), 22.2% (24/108) were discontinued, including 16.7% (4/24) stopped prior to and 83.3% (20/24) after starting enrollment. Only 28.4% of estimated enrollment was achieved for all discontinued RCT. Nineteen (79.2%) investigators provided a reason for discontinuation, which most commonly included poor enrollment (45.8%), inadequate supplies or funding (12.5%), and trial design concerns (8.3%). Of the 20 trials terminated following enrollment, 20.0% (4/20) were published in peer-reviewed journals and 80.0% (16/20) failed to reach publication. Of the 77.8% trials completed, 75.0% (63/84) were published and 25.0% (21/84) remain unpublished. In a multivariate regression of completed trials, industry funding was significantly associated with decreased likelihood of peer-reviewed publication (OR = 0.18, (95% CI 0.05-0.71), P = 0.01). Of the discontinued and completed trials remaining unpublished, 62.5% and 61.9% failed to report results on ClinicalTrials.gov, respectively, encompassing a total of 4,788 enrollees without publicly available results. CONCLUSIONS Nearly 25% of registered vascular RCT were discontinued. Of completed RCT, 25% remain unpublished with industry funding associated with decreased likelihood of publication. This study identifies opportunities to report all findings for completed and discontinued vascular surgery RCT, whether industry sponsored, or investigator initiated.
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Affiliation(s)
- Mary A Binko
- School of Medicine, University of Pittsburgh, Pittsburgh, PA
| | - Katherine M Reitz
- Division of Vascular Surgery, Department of Surgery, UPMC, Pittsburgh, PA
| | - Rabih A Chaer
- Division of Vascular Surgery, Department of Surgery, UPMC, Pittsburgh, PA
| | - Lindsey M Haga
- Division of Vascular Surgery, Department of Surgery, UPMC, Pittsburgh, PA
| | - Catherine Go
- Division of Vascular Surgery, Department of Surgery, UPMC, Pittsburgh, PA
| | | | - Edith Tzeng
- Division of Vascular Surgery, Department of Surgery, UPMC, Pittsburgh, PA
| | - Mohammad H Eslami
- Division of Vascular Surgery, Department of Surgery, UPMC, Pittsburgh, PA
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Velez MA, Glenn BA, Garcia-Jimenez M, Cummings AL, Lisberg A, Nañez A, Radwan Y, Lind-Lebuffe JP, Brodrick PM, Li DY, Fernandez-Turizo MJ, Gower A, Lindenbaum M, Hegde M, Brook J, Grogan T, Elashoff D, Teitell MA, Garon EB. Consent document translation expense hinders inclusive clinical trial enrolment. Nature 2023; 620:855-862. [PMID: 37532930 PMCID: PMC11046417 DOI: 10.1038/s41586-023-06382-0] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/14/2022] [Accepted: 06/28/2023] [Indexed: 08/04/2023]
Abstract
Patients from historically under-represented racial and ethnic groups are enrolled in cancer clinical trials at disproportionately low rates in the USA1-3. As these patients often have limited English proficiency4-7, we hypothesized that one barrier to their inclusion is the cost to investigators of translating consent documents. To test this hypothesis, we evaluated more than 12,000 consent events at a large cancer centre and assessed whether patients requiring translated consent documents would sign consent documents less frequently in studies lacking industry sponsorship (for which the principal investigator pays the translation costs) than for industry-sponsored studies (for which the translation costs are covered by the sponsor). Here we show that the proportion of consent events for patients with limited English proficiency in studies not sponsored by industry was approximately half of that seen in industry-sponsored studies. We also show that among those signing consent documents, the proportion of consent documents translated into the patient's primary language in studies without industry sponsorship was approximately half of that seen in industry-sponsored studies. The results suggest that the cost of consent document translation in trials not sponsored by industry could be a potentially modifiable barrier to the inclusion of patients with limited English proficiency.
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Affiliation(s)
- Maria A Velez
- Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA
| | - Beth A Glenn
- Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA
- Department of Health Policy and Management, University of California, Los Angeles, Los Angeles, CA, USA
- UCLA Center for Cancer Prevention and Control Research, University of California, Los Angeles, Los Angeles, CA, USA
- UCLA Kaiser Permanente Center for Health Equity, University of Califonia, Los Angeles, Los Angeles, CA, USA
| | - Maria Garcia-Jimenez
- Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA
- Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA
- Division of Hematology/Oncology, UCLA-Olive View Medical Center, Los Angeles, CA, USA
| | - Amy L Cummings
- Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA
- Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA
| | - Aaron Lisberg
- Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA
- Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA
| | - Andrea Nañez
- Department of Obstetrics and Gynecology, University of California, Los Angeles, Los Angeles, CA, USA
| | - Yazeed Radwan
- Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA
| | - Jackson P Lind-Lebuffe
- Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA
| | - Paige M Brodrick
- Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA
| | - Debory Y Li
- Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA
| | | | - Arjan Gower
- Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA
| | - Maggie Lindenbaum
- Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA
| | - Manavi Hegde
- Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA
| | - Jenny Brook
- Department of Medicine Statistics Core, University of California, Los Angeles, Los Angeles, CA, USA
| | - Tristan Grogan
- Department of Medicine Statistics Core, University of California, Los Angeles, Los Angeles, CA, USA
| | - David Elashoff
- Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA
- Department of Medicine Statistics Core, University of California, Los Angeles, Los Angeles, CA, USA
| | - Michael A Teitell
- Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA
- Department of Pathology and Laboratory Medicine, University of California, Los Angeles, Los Angeles, CA, USA
| | - Edward B Garon
- Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA.
- Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA.
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Varma T, Mello M, Ross JS, Gross C, Miller J. Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study. BMJ MEDICINE 2023; 2:e000395. [PMID: 36936269 PMCID: PMC9951369 DOI: 10.1136/bmjmed-2022-000395] [Citation(s) in RCA: 19] [Impact Index Per Article: 9.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/04/2022] [Accepted: 11/14/2022] [Indexed: 01/07/2023]
Abstract
Objective To develop a measure for fair inclusion in pivotal trials by assessing transparency and representation of enrolled women, older adults (aged 65 years and older), and racially and ethnically minoritized patients. Design Retrospective cross sectional study. Population Sponsors of novel oncology therapeutics that were approved by the US Food and Drug Administration over 1 January 2012 to 31 December 2017. Data sources Trial data from Drugs@FDA, ClinicalTrials.gov, and corresponding publications; cancer incidence demographics from US Cancer Statistics and the American Cancer Society. Main outcome measures Transparency measures assess whether trials publicly report participant sex, age, and racial and ethnic identity. Representation measures assess whether trial participant demographics represent more than 80% of the US patient population for studied conditions, calculated by dividing the percentage of study participants in each demographic subgroup by the percentage of the US cancer population with the studied condition per group. Composite fair inclusion measures assess average transparency and representation scores, overall and for each demographic group. Results are reported at the trial, product, and sponsor levels. Results Between 1 January 2012 and 31 December 2017, the FDA approved 59 novel cancer therapeutics, submitted by 25 sponsors (all industry companies) on the basis of 64 pivotal trials. All 25 sponsors (100%) reported participant sex, 10 (40%) reported age, and six (24%) reported race and ethnicity. Although 14 (56%) sponsors had adequate representation of women in trials, only six (24%) adequately represented older adults, and four (16%) adequately represented racially and ethnically minoritized patients (black, Asian, Hispanic or Latinx). On overall fair inclusion, one sponsor scored 100% and the median sponsor score was 81% (interquartile range 75-87%). More than half of sponsors (13 (56%) of 25) fairly included women, 20% (n=5) fairly included older adults, and 4% (n=1) fairly included racially and ethnically minoritized patients in trials. 80% of product had pivotal trials that fairly included women, 24% fairly included older adults, and 5% fairly included racially and ethnically minoritized patients. Conclusions This novel approach evaluates trials, products, and sponsors on their fair inclusion of demographic groups in research. For oncology trials, substantial room was noted for improved inclusion of older adults and patients who identify as black or Latinx and transparency around the number of participants identifying as Native Hawaiian, Pacific Islander, American Indian, and Alaska Native. These measures can be used by sponsors, ethics committees, among others, to set and evaluate trial diversity goals to help spur progress toward greater research equity in the US.
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Affiliation(s)
| | - Michelle Mello
- Stanford University Law School, Stanford, CA, USA
- School of Medicine, Stanford University, Stanford, CA, USA
- Freeman Spogli Institute for International Studies, Stanford University, Stanford, CA, USA
| | - Joseph S Ross
- Internal Medicine, Yale School of Medicine, New Haven, CT, USA
- Yale New Haven Hospital, New Haven, CT, USA
- Yale University School of Public Health, New Haven, CT, USA
| | - Cary Gross
- Yale University School of Public Health, New Haven, CT, USA
- Section of General Internal Medicine, Yale School of Medicine, New Haven, CT, USA
- Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, Yale University, New Haven, CT, USA
| | - Jennifer Miller
- Internal Medicine, Yale School of Medicine, New Haven, CT, USA
- Program for Biomedical Ethics; Yale Center for Interdisciplinary Bioethics, Yale School of Medicine, New Haven, CT, USA
- Bioethics International, New York, NY, USA
- Equity Research and Innovation Center, Yale School of Medicine, New Haven, CT, USA
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Ghaderi H, Gooshki ES, Kruger E. ETHICS IN MEDICAL RESEARCH AND PUBLISHING. CENTRAL ASIAN JOURNAL OF MEDICAL HYPOTHESES AND ETHICS 2022. [DOI: 10.47316/cajmhe.2022.3.3.02] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022] Open
Abstract
This review aims to provide a concise argument on the importance of ethics in scientific endeavors. Consideration should be given to all aspects of a research project, including, study design, approval process, execution, and publication. In addition, parameters such as human roles in research and human rights are noted. Furthermore, critical questions such as confidentiality, beneficence, and non-maleficent research are emphasized. Apart from the significance of data analysis, the adverse consequences of unethical behaviors such as plagiarism, data falsification, and research bias are investigated.
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Physician–Medical Manufacturing Industry Relationships: Perceptions of Malaysians. JOURNAL OF HEALTH MANAGEMENT 2022. [DOI: 10.1177/09720634221128383] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
The relations between physicians and the medical manufacturing industry(MMI) which includes pharmaceutical, medical device or implants or life science industry, etc., are well known. To promote better physician–patient relationship and to safeguard patients’ interest, it has been proposed to make physician–industry financial relations transparent and accessible to public. This study aimed to explore Malaysian public’s perceptions towards these relationships. A survey questionnaire was specifically prepared to meet the objective of the study after a review of the existing literature. Statements describing various types of physician–industry financial interactions were formulated based on previous research. The participants were instructed to mark their response to each statement based on a 5-point Likert scale ranging from strongly disagree to strongly agree. More than half (57.1%) of the participants were aware of the relationships between physicians and MMI and online database was noted to be the most preferred type of disclosure. Age, gender, race, education status, annual income and subjective health influenced the perceptions. Since consumers (patients) are the key stakeholders of the healthcare industry, their opinions are important. It is hoped that disclosing the financial relationships will help them to make a better-informed decision while choosing their healthcare provider.
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Ying X, Rosenblatt R, Fortune BE. Trends in Industry Payments to Gastroenterologists and Hepatologists in the United States From 2014 to 2020. Gastroenterology 2022; 163:787-791. [PMID: 35714706 DOI: 10.1053/j.gastro.2022.06.029] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/01/2022] [Revised: 06/01/2022] [Accepted: 06/04/2022] [Indexed: 12/02/2022]
Affiliation(s)
- Xiaohan Ying
- Department of Medicine, Weill Cornell Medicine, New York, New York
| | - Russell Rosenblatt
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York, New York
| | - Brett E Fortune
- Division of Hepatology, Montefiore-Albert Einstein College of Medicine, Bronx, New York
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Mohyuddin GR, Mehra N, Ryll B, Prasad V. Control participants of randomised trials: an often forgotten, vulnerable population. Lancet Haematol 2022; 9:e634-e636. [PMID: 36055323 DOI: 10.1016/s2352-3026(22)00254-x] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/29/2022] [Revised: 06/21/2022] [Accepted: 08/02/2022] [Indexed: 06/15/2023]
Affiliation(s)
- Ghulam Rehman Mohyuddin
- Division of Hematology, Huntsman Cancer Center, University of Utah, Salt Lake City, UT 84112, USA.
| | - Nikita Mehra
- Department of Medical Oncology and Molecular Oncology, Cancer Institute (WIA), Chennai, India
| | - Bettina Ryll
- Patient Advocates Working Group, Melanoma Patient Network Europe, European Society for Medical Oncology, Uppsala, Sweden
| | - Vinay Prasad
- Division of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA
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10
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Fogarty AE, Conger A, Burnham T. Systematic reviews: Not always a pain. INTERVENTIONAL PAIN MEDICINE 2022; 1:100128. [PMID: 39239125 PMCID: PMC11373034 DOI: 10.1016/j.inpm.2022.100128] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 05/16/2022] [Accepted: 06/27/2022] [Indexed: 09/07/2024]
Abstract
Systematic reviews analyze the evidence surrounding a specific intervention within a population. High quality systematic reviews can help clinicians and policymakers accurately understand a treatment intervention. This article outlines the basic principles of systematic review development, including assembling a research team, defining the research question, publishing a protocol, designing and executing the search, study selection, extracting the data, assessing risk of bias, synthesizing the data and conducting a certainty assessment. In addition, we will address common pitfalls and highlight special considerations for the field of interventional pain medicine. Understanding systematic review methodology will help investigators improve their primary research and in turn, better primary literature will improve the value of high quality reviews.
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Affiliation(s)
- Alexandra E Fogarty
- Department of Orthopedic Surgery, Division of Physical Medicine & Rehabilitation, Washington University School of Medicine, St. Louis, MO, USA
| | - Aaron Conger
- Department of Physical Medicine and Rehabilitation, University of Utah School of Medicine, Salt Lake City, UT, USA
| | - Taylor Burnham
- Department of Physical Medicine and Rehabilitation, University of Utah School of Medicine, Salt Lake City, UT, USA
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Abstract
Over the last decades, federal funding for medical research has decreased, while industry funding has increased. The majority of clinical trials are now industry funded. Involvement of industry raises documented concerns of reporting and publication bias, data suppression, and conclusions that may more favorably align with funder motivations rather than study results. However, industry involvement may also lead to scientific innovation, efficiency, and a more rapid timeline to bring new developments to patients. Through a careful review of a manuscript, the reader can understand the nature of industry involvement and interpret the results in this context.
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Affiliation(s)
- X Mona Guo
- Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Southern California, Los Angeles, California
| | - Emma L Barber
- Division of Gynecologic Oncology, Department of Obstetrics and Gynecology
- Robert H Lurie Comprehensive Cancer Center, Northwestern University
- Surgical Outcomes and Quality Improvement Center, Institute for Public Health in Medicine, Chicago, Illinois
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12
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Little M, Lipworth W, Kerridge I. An Archeology of Corruption in Medicine. JOURNAL OF BIOETHICAL INQUIRY 2022; 19:109-116. [PMID: 35362930 DOI: 10.1007/s11673-022-10178-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/14/2023]
Abstract
Corruption is a word used loosely to describe many kinds of action that people find distasteful. We prefer to reserve it for the intentional misuse of the good offices of an established social entity for private benefit, posing as fair trading. The currency of corruption is not always material or financial. Moral corruption is all too familiar within churches and other ostensibly beneficent institutions, and it happens within medicine and the pharmaceutical industries. Corrupt behavior reduces trust, costs money, causes injustice, and arouses anger. Yet it persists, despite all efforts since the beginnings of societies. People who act corruptly may lack conscience and empathy in the same way as those with some personality disorders. Finding ways to prevent corruption from contaminating beneficent organizations is therefore likely to be frustratingly difficult. Transparency and accountability may go some way, but the determined corruptor is unlikely to feel constrained by moral and reporting requirements of this kind. Punishment and redress are complicated issues, unlikely to satisfy victims and society at large. Both perhaps should deal in the same currency-material or social-in which the corrupt dealing took place.
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Affiliation(s)
- Miles Little
- Sydney Health Ethics, University of Sydney, Sydney, Australia
| | - Wendy Lipworth
- Sydney Health Ethics, University of Sydney, Sydney, Australia
| | - Ian Kerridge
- Sydney Health Ethics, University of Sydney, Sydney, Australia
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Tupetz A, Barcenas LK, Phillips AJ, Vissoci JRN, Gerardo CJ. BITES study: A qualitative analysis among emergency medicine physicians on snake envenomation management practices. PLoS One 2022; 17:e0262215. [PMID: 34995326 PMCID: PMC8741014 DOI: 10.1371/journal.pone.0262215] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/05/2021] [Accepted: 12/19/2021] [Indexed: 11/18/2022] Open
Abstract
INTRODUCTION Antivenom is currently considered standard treatment across the full spectrum of severity for snake envenomation in the United States. Although safe and effective antivenoms exist, their use in clinical practice is not universal. OBJECTIVE This study explored physicians' perceptions of antivenom use and experience with snake envenomation treatment in order to identify factors that influence treatment decisions and willingness to administer. METHODS We conducted a qualitative study including in-depth interviews via online video conferencing with physicians practicing in emergency departments across the United States. Participants were selected based on purposive sampling methods. Data analysis followed inductive strategies, conducted by two researchers. The codebook and findings were discussed within the research team. FINDINGS Sixteen in-depth interviews with physicians from nine states across the US were conducted. The participants' specialties include emergency medicine (EM), pediatric EM, and toxicology. The experience of treating snakebites ranged from only didactic education to having treated over 100 cases. Emergent themes for this manuscript from the interview data included perceptions of antivenom, willingness to administer antivenom and influencing factors to antivenom usage. Overall, cost-related concerns were a major barrier to antivenom administration, especially in cases where the indications and effectiveness did not clearly outweigh the potential financial burden on the patient in non-life- or limb-threatening cases. The potential to decrease recovery time and long-term functional impairments was not commonly reported by participants as an indication for antivenom. In addition, level of exposure and perceived competence, based on prior education and clinical experience, further impacted the decision to treat. Resources such as Poison Center Call lines were well received and commonly used to guide the treatment plan. The need for better clinical guidelines and updated treatment algorithms with clinical and measurable indicators was stated to help the decision-making process, especially among those with low exposure to snake envenomation patients. CONCLUSIONS A major barrier to physician use of antivenom is a concern about cost, cost transparency and cost-benefit for the patients. Those concerns, in addition to the varying degrees of awareness of potential long-term benefits, further influence inconsistent clinical treatment practices.
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Affiliation(s)
- Anna Tupetz
- Department of Surgery, Duke University School of Medicine, Durham, North Carolina, United States of America
| | - Loren K. Barcenas
- Department of Surgery, Duke University School of Medicine, Durham, North Carolina, United States of America
| | - Ashley J. Phillips
- Department of Surgery, Duke University School of Medicine, Durham, North Carolina, United States of America
| | - Joao Ricardo Nickenig Vissoci
- Department of Surgery, Duke University School of Medicine, Durham, North Carolina, United States of America
- Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America
| | - Charles J. Gerardo
- Department of Surgery, Duke University School of Medicine, Durham, North Carolina, United States of America
- Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America
- * E-mail:
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Anand AC, Acharya SK. Nonalcoholic Steatohepatitis, Peroxisome Proliferator-Activated Receptors and Our Good Glitazar: Proof of the Pudding is in the Eating. J Clin Exp Hepatol 2022; 12:263-267. [PMID: 35535098 PMCID: PMC9077217 DOI: 10.1016/j.jceh.2022.01.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022] Open
Affiliation(s)
- Anil C. Anand
- Address for correspondence: Anil C Anand, Professor and Head, Department of Gastroenterology & Hepatology, Kalinga Institute of Medical Sciences, Bhubaneswar, 751024 Odisha, India.
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15
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Wenger D, Nowlin R, Johnson AL, Anderson M, Weaver M, Hartwell M, Vassar M. Evaluation of Industry Relationships Among Authors of Systematic Reviews and Meta-analyses Regarding Ménières Disease. Ann Otol Rhinol Laryngol 2021; 131:1004-1012. [PMID: 34636251 DOI: 10.1177/00034894211051822] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
OBJECTIVES To quantify the presence of conflicts of interest (COI) in SRs and MAs of Ménières disease treatment and identify any related secondary characteristics of these articles. METHODS A search was conducted on May 28, 2020 to search MEDLINE and Embase databases for SRs or MAs pertaining to Ménières disease published between September 1, 2016 and June 2, 2020. A risk of bias assessment was performed using the Cochrane Collaboration risk of bias assessment criteria. RESULTS A total of 13 systematic reviews conducted by 49 authors met the inclusion criteria. Of the 49 authors, 7 (14.3%) were found to have some form of COI. Of these 7 authors, 1 (14.3%) completely disclosed all COI within the SR, 1 (14.3%) disclosed one or more COI but were found to have an additional undisclosed COI, and 5 (71.4%) were found to have only undisclosed COI. One of 2 industry funded SRs (50%) had a high risk of bias, and 1 (50%) of the non-industry sponsored SRs were found to have a high risk of bias. CONCLUSIONS Overall authors of SRs pertaining to Ménières disease appear to be properly disclosing COI at higher rates than other fields of medicine; however, further room for improvement has been noted.
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Affiliation(s)
- David Wenger
- Oklahoma State University Center for Health Sciences, Tulsa, OK, USA
| | - Ross Nowlin
- Oklahoma State University Center for Health Sciences, Tulsa, OK, USA
| | - Austin L Johnson
- Oklahoma State University Center for Health Sciences, Tulsa, OK, USA
| | - Michael Anderson
- Oklahoma State University Center for Health Sciences, Tulsa, OK, USA
| | - Michael Weaver
- Kansas City University of Medicine and Biosciences, Joplin, MO, USA
| | - Micah Hartwell
- Oklahoma State University Center for Health Sciences, Tulsa, OK, USA
| | - Matt Vassar
- Oklahoma State University Center for Health Sciences, Tulsa, OK, USA
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Cheng I, Hamdy S. Current perspectives on the benefits, risks, and limitations of noninvasive brain stimulation (NIBS) for post-stroke dysphagia. Expert Rev Neurother 2021; 21:1135-1146. [PMID: 34530656 DOI: 10.1080/14737175.2021.1974841] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/02/2021] [Accepted: 08/27/2021] [Indexed: 10/20/2022]
Abstract
INTRODUCTION Studies have shown that noninvasive brain stimulation (NIBS), including repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), can promote neuroplasticity, which is considered important for functional recovery of swallowing after stroke. Despite extensive studies on NIBS, there remains a gap between research and clinical practice. AREAS COVERED In this article, we update the current knowledge on the benefits and challenges of rTMS and tDCS for post-stroke dysphagia. We identify some key limitations of these techniques that hinder the translation from clinical trials to routine practice. Finally, we discuss the future of NIBS as a treatment for post-stroke dysphagia in real-world settings. EXPERT OPINION Current evidence suggests that rTMS and tDCS show promise as a treatment for post-stroke dysphagia. However, these techniques are limited by the response variability, uncertainty on the safety in patients with comorbidities and difficulties in clinical study designs. Such limitations call for further work to enhance their utility through individualized approaches. Despite this, the last decade has seen a growing acceptance toward these techniques among clinical personnel. As such, we advocate caution but support optimism that NIBS will gradually be recognized as a mainstream treatment approach for post-stroke dysphagia in the future.
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Affiliation(s)
- Ivy Cheng
- Centre for Gastrointestinal Sciences, Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
| | - Shaheen Hamdy
- Centre for Gastrointestinal Sciences, Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
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17
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Polson C, Siex P, Anderson JM, Weaver M, Roberts W, Hartwell M, Vassar M. Conflicts of interest among authors of systematic reviews regarding the management of chronic non-cancer pain with opioids analgesics. PAIN MEDICINE 2021; 23:305-313. [PMID: 34453825 DOI: 10.1093/pm/pnab223] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
OBJECTIVE We sought to determine whether author conflict of interest (disclosed or undisclosed) or industry sponsorship influenced the favorability of reporting of systematic reviews and meta-analyses investigating the use of opioid analgesics for the management of chronic non-cancer pain. METHODS Our search included the MEDLINE (Ovid) and Embase (Ovid) databases. Study sponsorship was determined using the funding statement provided in each systematic review. Author COI information was extracted from the COI disclosure statement. This information was cross-referenced with information available on the CMS Open Payments Database, Dollars for Profs, Google Patents, the United States Patent and Trademark Office (USPTO), and previously published COI disclosures. RESULTS Eight systematic reviews authored by 83 authors were included. Of these authors, 19 (23.0%) were found to have a COI, of which the majority (17/19; 89.5%) had at least one undisclosed COI. Despite nearly one-quarter of authors having a COI, we found no association between the presence of a COI and the favorability of results (p = 0.64) or conclusions (p = 0.07). CONCLUSION COI are common and frequently undisclosed among systematic review authors investigating opioid analgesics for the management of chronic non-cancer pain. Despite a high prevalence of COI, we did not find that these author-industry relationships had a significant influence on the favorability of results and conclusions; however, our findings should be considered a lower bound estimate of the true influence author COI have on outcomes of pain medicine systematic reviews secondary to the low sample size included in the present study.
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Affiliation(s)
- Connor Polson
- Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
| | - Parker Siex
- Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
| | - J Michael Anderson
- Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
| | - Michael Weaver
- Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma.,Kansas City University of Medicine and Biosciences, College of Osteopathic Medicine, Joplin, Missouri
| | - Will Roberts
- Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
| | - Micah Hartwell
- Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma.,Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
| | - Matt Vassar
- Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma.,Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma
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18
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Mentzelopoulos SD, Couper K, Van de Voorde P, Druwé P, Blom M, Perkins GD, Lulic I, Djakow J, Raffay V, Lilja G, Bossaert L. [Ethics of resuscitation and end of life decisions]. Notf Rett Med 2021; 24:720-749. [PMID: 34093076 PMCID: PMC8170633 DOI: 10.1007/s10049-021-00888-8] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 04/19/2021] [Indexed: 12/14/2022]
Abstract
These European Resuscitation Council Ethics guidelines provide evidence-based recommendations for the ethical, routine practice of resuscitation and end-of-life care of adults and children. The guideline primarily focus on major ethical practice interventions (i.e. advance directives, advance care planning, and shared decision making), decision making regarding resuscitation, education, and research. These areas are tightly related to the application of the principles of bioethics in the practice of resuscitation and end-of-life care.
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Affiliation(s)
- Spyros D. Mentzelopoulos
- Evaggelismos Allgemeines Krankenhaus, Abteilung für Intensivmedizin, Medizinische Fakultät der Nationalen und Kapodistrischen Universität Athen, 45–47 Ipsilandou Street, 10675 Athen, Griechenland
| | - Keith Couper
- Universitätskliniken Birmingham NHS Foundation Trust, UK Critical Care Unit, Birmingham, Großbritannien
- Medizinische Fakultät Warwick, Universität Warwick, Coventry, Großbritannien
| | - Patrick Van de Voorde
- Universitätsklinikum und Universität Gent, Gent, Belgien
- staatliches Gesundheitsministerium, Brüssel, Belgien
| | - Patrick Druwé
- Abteilung für Intensivmedizin, Universitätsklinikum Gent, Gent, Belgien
| | - Marieke Blom
- Medizinisches Zentrum der Universität Amsterdam, Amsterdam, Niederlande
| | - Gavin D. Perkins
- Medizinische Fakultät Warwick, Universität Warwick, Coventry, Großbritannien
| | | | - Jana Djakow
- Intensivstation für Kinder, NH Hospital, Hořovice, Tschechien
- Abteilung für Kinderanästhesiologie und Intensivmedizin, Universitätsklinikum und Medizinische Fakultät der Masaryk-Universität, Brno, Tschechien
| | - Violetta Raffay
- School of Medicine, Europäische Universität Zypern, Nikosia, Zypern
- Serbischer Wiederbelebungsrat, Novi Sad, Serbien
| | - Gisela Lilja
- Universitätsklinikum Skane, Abteilung für klinische Wissenschaften Lund, Neurologie, Universität Lund, Lund, Schweden
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Undercutting efforts of precision medicine: roadblocks to minority representation in breast cancer clinical trials. Breast Cancer Res Treat 2021; 187:605-611. [PMID: 34080093 DOI: 10.1007/s10549-021-06264-x] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/18/2021] [Accepted: 05/18/2021] [Indexed: 12/16/2022]
Abstract
Precision (or personalized) medicine holds great promise in the treatment of breast cancer. The success of personalized medicine is contingent upon inclusivity and representation for minority groups in clinical trials. In this article, we focus on the roadblocks for the African American demographic, including the barriers to access and enrollment in breast oncology trials, the prevailing classification of race and ethnicity, and the need to refine monolithic categorization by employing genetic ancestry mapping tools for a more accurate determination of race or ethnicity.
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20
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Zhang Y, Michelakis ED. A Phase-2 NIH-sponsored Randomized Clinical Trial of Rituximab in Scleroderma-associated Pulmonary Arterial Hypertension Did Not Reach Significance for Its Endpoints: End of Story? Not So Fast! Am J Respir Crit Care Med 2021; 204:123-125. [PMID: 33856964 PMCID: PMC8650784 DOI: 10.1164/rccm.202103-0612ed] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022] Open
Affiliation(s)
- Yongneng Zhang
- Department of Medicine University of Alberta Edmonton, Alberta, Canada
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21
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Ford KL, Portz JD, Zhou S, Gornail S, Moore SL, Zhang X, Bull S. Benefits, Facilitators, and Recommendations for Digital Health Academic-Industry Collaboration: A Mini Review. Front Digit Health 2021; 3:616278. [PMID: 34713094 PMCID: PMC8521882 DOI: 10.3389/fdgth.2021.616278] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/11/2020] [Accepted: 02/24/2021] [Indexed: 12/23/2022] Open
Abstract
Digital health remains a growing and challenging niche in public health practice. Academic-industry collaboration (AIC) offers a mechanism to bring disparate sectors together to alleviate digital health challenges of engagement, reach, sustainability, dissemination, evaluation, and equity. Despite the ongoing endorsements for AIC in digital health, limited understanding exists of successful AIC exists. Most published research highlights the barriers of collaboration rather than efficacy, leaving collaborators asking: What are the benefits and facilitators of AIC and do they apply in digital health? As an initial effort to fill the gap in the literature, the purpose of this mini review outlines the benefits and facilitators from previous AIC and offers recommendations specific to digital health.
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Affiliation(s)
- Kelsey L. Ford
- Colorado School of Public Health, University of Colorado, Anschutz Medical Campus, Aurora, CO, United States
- School of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, CO, United States
| | - Jennifer D. Portz
- Colorado School of Public Health, University of Colorado, Anschutz Medical Campus, Aurora, CO, United States
- School of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, CO, United States
| | - Shuo Zhou
- Colorado School of Public Health, University of Colorado, Anschutz Medical Campus, Aurora, CO, United States
| | - Starlynne Gornail
- Colorado School of Public Health, University of Colorado, Anschutz Medical Campus, Aurora, CO, United States
| | - Susan L. Moore
- Colorado School of Public Health, University of Colorado, Anschutz Medical Campus, Aurora, CO, United States
| | - Xuhong Zhang
- Colorado School of Public Health, University of Colorado, Anschutz Medical Campus, Aurora, CO, United States
| | - Sheana Bull
- Colorado School of Public Health, University of Colorado, Anschutz Medical Campus, Aurora, CO, United States
- School of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, CO, United States
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22
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Mentzelopoulos SD, Couper K, Voorde PVD, Druwé P, Blom M, Perkins GD, Lulic I, Djakow J, Raffay V, Lilja G, Bossaert L. European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions. Resuscitation 2021; 161:408-432. [PMID: 33773832 DOI: 10.1016/j.resuscitation.2021.02.017] [Citation(s) in RCA: 128] [Impact Index Per Article: 32.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
These European Resuscitation Council Ethics guidelines provide evidence-based recommendations for the ethical, routine practice of resuscitation and end-of-life care of adults and children. The guideline primarily focus on major ethical practice interventions (i.e. advance directives, advance care planning, and shared decision making), decision making regarding resuscitation, education, and research. These areas are tightly related to the application of the principles of bioethics in the practice of resuscitation and end-of-life care.
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Affiliation(s)
| | - Keith Couper
- UK Critical Care Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Warwick Medical School, University of Warwick, Coventry, UK
| | - Patrick Van de Voorde
- University Hospital and University Ghent, Belgium; Federal Department Health, Belgium
| | - Patrick Druwé
- Ghent University Hospital, Department of Intensive Care Medicine, Ghent, Belgium
| | - Marieke Blom
- Amsterdam University Medical Center, Amsterdam, The Netherlands
| | - Gavin D Perkins
- UK Critical Care Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
| | | | - Jana Djakow
- Paediatric Intensive Care Unit, NH Hospital, Hořovice, Czech Republic; Department of Paediatric Anaesthesiology and Intensive Care Medicine, University Hospital and Medical Faculty of Masaryk University, Brno, Czech Republic
| | - Violetta Raffay
- European University Cyprus, School of Medicine, Nicosia, Cyprus; Serbian Resuscitation Council, Novi Sad, Serbia
| | - Gisela Lilja
- Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Neurology, Lund, Sweden
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23
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Clinical trials in otology: Examining trends and framework for prioritization. J Otol 2020; 16:95-98. [PMID: 33777122 PMCID: PMC7985013 DOI: 10.1016/j.joto.2020.11.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/11/2020] [Revised: 11/25/2020] [Accepted: 11/25/2020] [Indexed: 11/23/2022] Open
Abstract
Objective To characterize otologic clinical trials and examine otologic clinical trial trends from 2008 to 2018 using the clinicaltrials.gov database. Methods Data was collected from clinicaltrials.gov and included all clinical trials that focused on otology from 2008 to 2018. Outcome measures include status of trials, funding sources, details regarding otologic conditions studied, and trends in clinical trials. Results There were 992 otology clinical trials from 2008 to 2018.457 (46.1%) were completed and 94 (9.5%) were discontinued. Industry remained the highest (76.5%) contributor to otology clinical trials. The otologic conditions studied, from most common to least common, include hearing loss (40.6%), vestibulopathy (18.8%), tinnitus (18.8%), and otitis media (15.1%). The number of otology clinical trials increased by an average of 12.0 trials per year from 2008 to 2018 (p < 0.001). The number of otology clinical trials focusing on hearing loss and vestibulopathy significantly increased over the studied period (p < 0.001), while those focusing on tinnitus and otitis media did not (p = 0.09 and p = 0.20, respectively). The majority of clinical trials on each of these four conditions focused on treatment options. Conclusion Our study describes trends in otology clinical trials registered on clinicaltrials.gov from 2008 through 2018. The total number of clinical trials over this time period increased significantly, driven by trials investigating hearing loss and vestibulopathy. Furthermore, most clinical trials were industry-sponsored and focused on treatment modalities. Our study provides an outline of otology clinical trials registered in a US web-based database, which may be of use for the development of future clinical trials.
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Araujo SC, Pereira LR, Alves RPS, Andreata-Santos R, Kanno AI, Ferreira LCS, Gonçalves VM. Anti-Flavivirus Vaccines: Review of the Present Situation and Perspectives of Subunit Vaccines Produced in Escherichia coli. Vaccines (Basel) 2020; 8:vaccines8030492. [PMID: 32878023 PMCID: PMC7564369 DOI: 10.3390/vaccines8030492] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/23/2020] [Revised: 08/22/2020] [Accepted: 08/23/2020] [Indexed: 12/14/2022] Open
Abstract
This article aims to review the present status of anti-flavivirus subunit vaccines, both those at the experimental stage and those already available for clinical use. Aspects regarding development of vaccines to Yellow Fever virus, (YFV), Dengue virus (DENV), West Nile virus (WNV), Zika virus (ZIKV), and Japanese encephalitis virus (JEV) are highlighted, with particular emphasis on purified recombinant proteins generated in bacterial cells. Currently licensed anti-flavivirus vaccines are based on inactivated, attenuated, or virus-vector vaccines. However, technological advances in the generation of recombinant antigens with preserved structural and immunological determinants reveal new possibilities for the development of recombinant protein-based vaccine formulations for clinical testing. Furthermore, novel proposals for multi-epitope vaccines and the discovery of new adjuvants and delivery systems that enhance and/or modulate immune responses can pave the way for the development of successful subunit vaccines. Nonetheless, advances in this field require high investments that will probably not raise interest from private pharmaceutical companies and, therefore, will require support by international philanthropic organizations and governments of the countries more severely stricken by these viruses.
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Affiliation(s)
- Sergio C. Araujo
- Laboratory of Vaccine Development, Instituto Butantan, São Paulo–SP 05503-900, Brazil; (S.C.A.); (A.I.K.)
| | - Lennon R. Pereira
- Laboratory of Vaccine Development, Institute of Biomedical Sciences, Universidade de São Paulo, São Paulo–SP 05508-000, Brazil; (L.R.P.); (R.P.S.A.); (R.A.-S.)
| | - Rubens P. S. Alves
- Laboratory of Vaccine Development, Institute of Biomedical Sciences, Universidade de São Paulo, São Paulo–SP 05508-000, Brazil; (L.R.P.); (R.P.S.A.); (R.A.-S.)
| | - Robert Andreata-Santos
- Laboratory of Vaccine Development, Institute of Biomedical Sciences, Universidade de São Paulo, São Paulo–SP 05508-000, Brazil; (L.R.P.); (R.P.S.A.); (R.A.-S.)
| | - Alex I. Kanno
- Laboratory of Vaccine Development, Instituto Butantan, São Paulo–SP 05503-900, Brazil; (S.C.A.); (A.I.K.)
| | - Luis Carlos S. Ferreira
- Laboratory of Vaccine Development, Institute of Biomedical Sciences, Universidade de São Paulo, São Paulo–SP 05508-000, Brazil; (L.R.P.); (R.P.S.A.); (R.A.-S.)
- Correspondence: (L.C.S.F.); (V.M.G.)
| | - Viviane M. Gonçalves
- Laboratory of Vaccine Development, Instituto Butantan, São Paulo–SP 05503-900, Brazil; (S.C.A.); (A.I.K.)
- Correspondence: (L.C.S.F.); (V.M.G.)
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Khan MS, Shahid I, Siddiqi TJ, Khan SU, Warraich HJ, Greene SJ, Butler J, Michos ED. Ten-Year Trends in Enrollment of Women and Minorities in Pivotal Trials Supporting Recent US Food and Drug Administration Approval of Novel Cardiometabolic Drugs. J Am Heart Assoc 2020; 9:e015594. [PMID: 32427023 PMCID: PMC7428976 DOI: 10.1161/jaha.119.015594] [Citation(s) in RCA: 91] [Impact Index Per Article: 18.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/16/2020] [Accepted: 04/24/2020] [Indexed: 01/02/2023]
Abstract
Background In 1993, the US Food and Drug Administration established guidelines to increase diversity by sex and race/ethnicity of participants in clinical trials supporting novel drug approvals. In this study we investigated the 10-year trends of participation of women and minorities in pivotal trials supporting approval of new molecular entities in cardiometabolic drugs from January 2008 to December 2017. Methods and Results A list of new molecular entities was abstracted from publicly available data at Drugs@Fda. Sex and race/ethnicity data were collected from trial publications. Linear regression analysis was performed to assess the relation between drug approval year and proportion of women and minorities enrolled. Thirty-five novel cardiovascular (n=24) and diabetes mellitus (n=11) drugs were approved by the US Food and Drug Administration during the study period. The median number of participants supporting each drug was 5930 (interquartile range, 3175-10 942). Women represented 36% (n=108 052) of trial participants (n=296 163). Women were underrepresented compared with their proportion of the disease population in trials of coronary heart disease (participation-to-prevalence ratio, 0.52), heart failure (participation-to-prevalence ratio, 0.58), and acute coronary syndrome (participation-to-prevalence ratio, 0.68). Among trial participants, 81% were white, 4% black, 12% Asian, and 11% Hispanic/Latino. There was no significant association between enrollment of women (P=0.29) or underrepresented minorities (P=0.45) with the drug approval year. Conclusions Over the past decade (2008-2017), women and minorities, particularly blacks, have continued to be inadequately represented in pivotal cardiometabolic clinical trials that support US Food and Drug Administration approval of new molecular entities. This may have major implications in determining efficacy of such therapies in these groups, and may impair generalizability of trial results to routine clinical practice.
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Affiliation(s)
| | - Izza Shahid
- Department of Internal MedicineZiauddin Medical UniversityKarachiPakistan
| | - Tariq Jamal Siddiqi
- Department of Internal MedicineDow University of Health SciencesKarachiPakistan
| | - Safi U. Khan
- Department of Internal MedicineWest Virginia UniversityMorgantownWV
| | | | | | - Javed Butler
- Department of MedicineUniversity of Mississippi Medical CenterJacksonMS
| | - Erin D. Michos
- Division of CardiologyJohns Hopkins Ciccarone Center for the Prevention of Cardiovascular DiseaseBaltimoreMD
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Raus K, Mortier E, Eeckloo K. Past, present and future of university hospitals. Acta Clin Belg 2020; 75:177-184. [PMID: 30896377 DOI: 10.1080/17843286.2019.1590024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/27/2022]
Abstract
Objectives: Health care systems worldwide are changing and taking new forms. The old, more hierarchically oriented, model with individual institutional and bilateral interactions between primary, secondary, tertiary and quaternary care is being replaced by an integrated and dynamic network model. We aim to look at what role university hospitals will play in this future organization of health care.Method: In this paper, we look at the relevant literature on the history of academic medicine and university hospitals. Subsequently, we look at the challenges university hospitals are facing according to contemporary literature on the topic.Results: Our current model of academic medicine with its university hospitals finds its origin in the institutionalization of the academic mission in the late 18th century. Currently, the sustainability of the model is under immense pressure. University hospitals are facing economic challenges, teaching challenges and research challenges. However, there is reason to believe that they can continue to play a role of importance in tomorrow's medicine. The organization of health care is undergoing two important changes. The first is the evolution towards a more dynamic and integrated network model. University hospitals can become an important hub within this network. The second change is an evolution towards evidence based medicine and translational research.Conclusion: Due to their unique tripartite mission, we argue that university hospitals can continue to play an important and critical role in promoting evidence-based medicine and speedy translation of new evidence.
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Affiliation(s)
- Kasper Raus
- Strategic policy cell, Ghent University Hospital, Ghent, Belgium
| | - Eric Mortier
- General management, Ghent University Hospital, Ghent, Belgium
- Faculty of Medicine & Health Sciences, Ghent University, Ghent, Belgium
| | - Kristof Eeckloo
- General management, Ghent University Hospital, Ghent, Belgium
- Department of Public Health, Ghent University, Ghent, Belgium
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27
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Omer S, Bakaeen FG. The Budget. Clin Trials 2020. [DOI: 10.1007/978-3-030-35488-6_13] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
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Ayoub NM, Qandil AM, McCutchan JA. Knowledge, Attitudes, and Practice Regarding Research Ethics Committees Among Health Care Faculty at Two Public Universities in Jordan. J Empir Res Hum Res Ethics 2019; 14:372-382. [PMID: 31169072 PMCID: PMC10923338 DOI: 10.1177/1556264619851351] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
Human research at Jordanian universities is increasing. This descriptive cross-sectional survey assessed knowledge, attitudes, and practices concerning the procedures and review process of research ethics committees (RECs) among faculty in health sciences in two major Jordanian universities. Most faculty reported having no training in research ethics in their current institutions. Although knowledge of RECs' roles and functions was adequate, deficiencies were found regarding the advisory and monitoring roles for RECs raised in this survey. Faculty expressed concerns about levels of ethical training for members of RECs and potential conflicts of interest and bias in review process. RECs should provide ethics training for faculty, and future research should examine the functioning of the RECs in Jordan and other Middle Eastern countries.
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Affiliation(s)
- Nehad M. Ayoub
- Jordan University of Science and Technology, Irbid, Jordan
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Seidler AL, Hunter KE, Chartres N, Askie LM. Associations between industry involvement and study characteristics at the time of trial registration in biomedical research. PLoS One 2019; 14:e0222117. [PMID: 31553736 PMCID: PMC6760823 DOI: 10.1371/journal.pone.0222117] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/25/2019] [Accepted: 08/21/2019] [Indexed: 11/19/2022] Open
Abstract
BACKGROUND Commercial or industry funding is associated with outcomes that favour the study funder in published studies, across various areas of research. However, it is currently unclear whether there are differences between trials with and without industry involvement at the stage of trial registration. OBJECTIVE To determine whether industry involvement (industry sponsorship, funding, or collaboration) is associated with trial characteristics at the time of trial registration. METHODS We conducted a cross-sectional analysis of all interventional studies registered on the Australian New Zealand Clinical Trials Registry in 2017 and classified them by industry involvement. We analysed whether there were differences in study characteristics (including type of control, sample size, study phase, randomisation, registration timing, and purpose of study) by industry involvement. RESULTS Industry involvement was reported by 21% of the 1,433 included trials. Only 40% of trials with industry involvement used an active control compared to 58% of non-industry trials (OR = 0.49, 95%CI = 0.38 to 0.63, p < .001), and industry trials reported smaller sample sizes (Median(IQR)industry = 45(24-100), Median(IQR)non-industry = 70(35-160), Mean Difference = -153, 95% CI = -233 to -75, p < .001). Industry trials were more likely to be earlier phase trials (Χ2(df) = 71.46(4), p < .001). There was no difference in use of randomisation between industry (70%) and non-industry trials (73%) (OR = 0.88, 95%CI = 0.67-1.20, p = .38). Eighty-three percent of industry trials compared to 70% of non-industry trials were prospectively registered (OR = 2.02, 95%CI = 1.47-2.82, p < .001). Industry trials were more likely to assess treatment (85%), rather than prevention, education or diagnosis compared to non-industry trials (64%) (OR = 3.02, 95%CI = 2.17-4.32, p < .001). CONCLUSION The current study gives insight into differences in trial characteristics by industry involvement at registration stage. There was a reduced use of active controls in trials with industry involvement which has previously been proposed as a mechanism behind more favourable results. Non-industry funders and sponsors are crucial to ensure research addresses not only treatments, but also prevention, diagnosis and education questions.
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Affiliation(s)
- Anna Lene Seidler
- NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia
| | - Kylie E. Hunter
- NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia
| | | | - Lisa M. Askie
- NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia
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Photoselective vaporization of the prostate: study outcomes as a function of risk of bias, conflicts of interest, and industrial sponsorship. World J Urol 2019; 38:741-746. [DOI: 10.1007/s00345-019-02799-3] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/25/2019] [Accepted: 05/03/2019] [Indexed: 01/20/2023] Open
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Lieber AM, Kirchner GJ, Zavras AG, Kerbel YE, Khalsa AS. Industry Consulting Payments to Orthopedic Surgeons Are Associated With Increased Publications. Orthopedics 2019; 42:137-142. [PMID: 31099878 DOI: 10.3928/01477447-20190424-03] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/29/2018] [Accepted: 02/25/2019] [Indexed: 02/03/2023]
Abstract
In accordance with the Physician Payment Sunshine Act, all industry payments to physicians in the United States have become publicly available. Previous research has indicated that orthopedic surgeons receive the greatest amount of industry compensation compared with other surgical subspecialists. However, the relationship between this compensation and research productivity is less clear. This study sought to investigate the relationship between consulting fees paid to orthopedic surgeons and academic productivity. Using the Centers for Medicare & Medicaid Services Open Payments Database, this study identified 2555 orthopedic surgeons who received at least one industry consulting fee in 2015. Physicians who received total consulting fees of at least $20,000 (US) were stratified into the high payment group. The number of publications and the h-index for each physician were used as metrics of scholarly impact. Mean publication number and h-index for the high payment group were compared with all other physicians in the sample using an independent-samples t test. A total of 2555 orthopedic surgeons received consulting payments totaling $62,323,143 in 2015. The mean consulting payment was $24,393 (SD, $45,465). The publication number was greater for the high payment group (mean, 61.6; SD, 135.6) compared with all other physicians in the sample (mean, 36.1; SD, 95.6). Additionally, the mean h-index for the high payment group was 13.7 (SD, 14.3) compared with 10.0 (SD, 11.6) for all other orthopedic surgeons. These findings indicate that the orthopedic surgeons who receive more in industry consulting fees are also those who contribute most substantially to the body of orthopedic literature. [Orthopedics. 2019; 42(3):137-142.].
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Anjorin A, Lipsky P. Engaging African ancestry participants in SLE clinical trials. Lupus Sci Med 2018; 5:e000297. [PMID: 30613420 PMCID: PMC6307590 DOI: 10.1136/lupus-2018-000297] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/26/2018] [Revised: 10/19/2018] [Accepted: 10/25/2018] [Indexed: 01/16/2023]
Abstract
SLE is a complex autoimmune disease with genetic and clinical differences between patients that appear to reside along ancestral lines. Over the last 20 years, a preponderance of evidence has shown that SLE is more common and severe in minority populations, particularly in African ancestry (AA) women. However, in clinical trials for new therapies of SLE, AA is often under-represented. Without enrolling sufficient AA participants, it is difficult to ascertain the safety and efficacy of new potential therapies among individuals with SLE of different ancestries. Although enrolling minority populations in clinical trials has been a significant challenge for many reasons, the various stakeholders involved in clinical research could act within their own realms to develop new paradigms and policies to bolster the inclusion of AA in the development of new therapies.
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Affiliation(s)
- Aderike Anjorin
- RILITE Research Institute, and University of Virginia, Charlottesville, Virginia, USA
| | - Peter Lipsky
- RILITE Research Institute, Charlottesville, Virginia, USA
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Sheridan DC, Ma OJ, Hansen ML. Emergency physicians can be leaders in clinical innovation: Tips to JumpStart the engine. Am J Emerg Med 2018; 37:1198-1199. [PMID: 30366743 DOI: 10.1016/j.ajem.2018.10.037] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/18/2018] [Revised: 10/18/2018] [Accepted: 10/18/2018] [Indexed: 11/18/2022] Open
Affiliation(s)
- David C Sheridan
- Department of Emergency Medicine, Oregon Health & Science University, United States of America.
| | - O John Ma
- Department of Emergency Medicine, Oregon Health & Science University, United States of America
| | - Matthew L Hansen
- Department of Emergency Medicine, Oregon Health & Science University, United States of America
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Affiliation(s)
- Paula A Rochon
- Women's College Research Institute, Women's College Hospital, Toronto, ON, Canada
- Division of Geriatric Medicine, Department of Medicine, University of Toronto, ON, Canada
| | - Nathan M Stall
- Women's College Research Institute, Women's College Hospital, Toronto, ON, Canada
- Division of Geriatric Medicine, Department of Medicine, University of Toronto, ON, Canada
| | - Rachel D Savage
- Women's College Research Institute, Women's College Hospital, Toronto, ON, Canada
| | - An-Wen Chan
- Women's College Research Institute, Women's College Hospital, Toronto, ON, Canada
- Division of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada
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Rasmussen K, Bero L, Redberg R, Gøtzsche PC, Lundh A. Collaboration between academics and industry in clinical trials: cross sectional study of publications and survey of lead academic authors. BMJ 2018; 363:k3654. [PMID: 30282703 PMCID: PMC6169401 DOI: 10.1136/bmj.k3654] [Citation(s) in RCA: 38] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 07/30/2018] [Indexed: 11/20/2022]
Abstract
OBJECTIVES To determine the role of academic authors, funders, and contract research organisations in industry funded trials of vaccines, drugs, and devices and to determine lead academic authors' experiences with industry funder collaborations. DESIGN Cross sectional analysis of trial publications and survey of lead academic authors. ELIGIBILITY CRITERIA FOR SELECTING STUDIES The most recent 200 phase III and IV trials of vaccines, drugs, and devices with full industry funding, at least one academic author, published in one of the top seven high impact general medical journals (New England Journal of Medicine, Lancet, JAMA, BMJ, Annals of Internal Medicine, JAMA Internal Medicine, and PLoS Medicine). RESULTS Employees of industry funders co-authored 173 (87%) of publications; 183 (92%) trials reported involvement of funders in design, and 167 (84%) reported involvement of academic authors. Data analysis involved the funder in 146 (73%) trials and the academic authors in 79 (40%). Trial reporting involved the funder in 173 (87%) trials and academic authors in 197 (99%). Contract research organisations were involved in the reporting of 123 (62%) trials.Eighty (40%) of 200 lead academic authors responded to the survey. Twenty nine (33%) of the 80 responders reported that academics had final say on the design. Ten responders described involvement of an unnamed funder and/or contract research organisation employee in the data analysis and/or reporting. Most academic authors found the collaboration with industry funder beneficial, but 3 (4%) experienced delay in publication due to the industry funder and 9 (11%) reported disagreements with the industry funder, mostly concerning trial design and reporting. CONCLUSIONS Industry employees and academic authors are involved in the design, conduct, and reporting of most industry funded trials in high impact journals. However, data analysis is often conducted without academic involvement. Academics view the collaboration as beneficial, but some report loss of academic freedom.
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Affiliation(s)
| | - Lisa Bero
- Charles Perkins Centre and Faculty of Pharmacy, University of Sydney, Sydney, NSW, Australia
| | - Rita Redberg
- UCSF Division of Cardiology, San Francisco, CA, USA
| | | | - Andreas Lundh
- Centre for Evidence-Based Medicine Odense (CEBMO) and Odense Patient data Exploratory Network (OPEN), Odense University Hospital, Odense, Denmark
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Ryan CW. Mechanisms and funding opportunities in genitourinary cancer clinical research. Urol Oncol 2018; 37:318-323. [PMID: 30072304 DOI: 10.1016/j.urolonc.2018.05.024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/02/2017] [Revised: 05/21/2018] [Accepted: 05/26/2018] [Indexed: 11/16/2022]
Abstract
Progress in the prevention, diagnosis, and treatment of genitourinary cancers is dependent on well-conducted clinical trials. The complexity and cost of clinical research continues to escalate, and success is dependent on adequate funding. Opportunities to fund such research include federal, industry, and private sources. The mechanisms whereby larger trials are conducted include contract research organizations, publically- and privately funded consortia, and the National Clinical Trials Network of the National Cancer Institute. The National Clinical Trials Network is the prime venue for investigators to conduct independent, phase III trials in the United States.
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Affiliation(s)
- Christopher W Ryan
- Professor of Medicine, Knight Cancer Center, Oregon Health & Science University, Portland, OR.
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Dogan S, Yamamoto-Ibusuki M, Andre F. Funding sources of practice-changing trials. Ann Oncol 2018; 29:1063-1065. [DOI: 10.1093/annonc/mdx798] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022] Open
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Tibau A, Anguera G, Andrés-Pretel F, Templeton AJ, Seruga B, Barnadas A, Amir E, Ocana A. Role of cooperative groups and funding source in clinical trials supporting guidelines for systemic therapy of breast cancer. Oncotarget 2018; 9:15061-15067. [PMID: 29599926 PMCID: PMC5871097 DOI: 10.18632/oncotarget.24589] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/08/2017] [Accepted: 02/21/2018] [Indexed: 11/25/2022] Open
Abstract
Introduction Clinical research is conducted by academia, cooperative groups (CGs) or pharmaceutical industry. Here, we evaluate the role of CGs and funding sources in the development of guidelines for breast cancer therapies. Results We identified 94 studies. CGs were involved in 28 (30%) studies while industry either partially or fully sponsored 64 (68%) studies. The number of industry funded studies increased over time (from 0% in 1976 to 100% in 2014; p for trend = 0.048). Only 10 (11%) government or academic studies were identified. Studies conducted by GCs included a greater number of subjects (median 448 vs. 284; p = 0.015), were more common in the neo/adjuvant setting (p < 0.0001), and were more often randomized (p = 0.018) phase III (p < 0.0001) trials. Phase III trial remained significant predictor for CG-sponsored trials (OR 7.1 p = 0.004) in a multivariable analysis. Industry funding was associated with higher likelihood of positive outcomes favoring the sponsored experimental arm (p = 0.013) but this relationship was not seen for CG-sponsored trials (p = 0.53). Materials and Methods ASCO, ESMO, and NCCN guidelines were searched to identify systemic anti-cancer therapies for early-stage and metastatic breast cancer. Trial characteristics and outcomes were collected. We identified sponsors and/or the funding source(s) and determined whether CGs, industry, or government or academic institutions were involved. Chi-square tests were used for comparison between studies. Conclusions Industry funding is present in the majority of studies providing the basis for which recommendations about treatment of breast cancer are made. Industry funding, but not CG-based funding, was associated with higher likelihood of positive outcomes in clinical studies supporting guidelines for systemic therapy.
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Affiliation(s)
- Ariadna Tibau
- Oncology Department, Hospital de la Santa Creu i Sant Pau and Universitat Autònoma de Barcelona, Barcelona, Spain
| | - Geòrgia Anguera
- Oncology Department, Hospital de la Santa Creu i Sant Pau and Universitat Autònoma de Barcelona, Barcelona, Spain
| | | | - Arnoud J Templeton
- Department of Medical Oncology, St Claraspital, Basel and Faculty of Medicine, University of Basel, Basel, Switzerland
| | - Bostjan Seruga
- Department of Medical Oncology, Institute of Oncology Ljubljana and University of Ljubljana, Ljubljana, Slovenia
| | - Agustí Barnadas
- Oncology Department, Hospital de la Santa Creu i Sant Pau and Universitat Autònoma de Barcelona, Barcelona, Spain
| | - Eitan Amir
- Division of Medical Oncology and Hematology, Department of Medicine, Princess Margaret Cancer Centre and the University of Toronto, Toronto, Ontario, Canada
| | - Alberto Ocana
- Translational Research Unit, Albacete University Hospital, Centro Regional de Investigaciones Biomédicas, Universidad de Castilla La Mancha, CIBERONC, Albacete, Spain
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Khan NR, Saad H, Oravec CS, Rossi N, Nguyen V, Venable GT, Lillard JC, Patel P, Taylor DR, Vaughn BN, Kondziolka D, Barker FG, Michael LM, Klimo P. A Review of Industry Funding in Randomized Controlled Trials Published in the Neurosurgical Literature—The Elephant in the Room. Neurosurgery 2018; 83:890-897. [DOI: 10.1093/neuros/nyx624] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/19/2017] [Accepted: 12/18/2017] [Indexed: 11/13/2022] Open
Affiliation(s)
- Nickalus R Khan
- Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee
| | - Hassan Saad
- Arkansas Neuroscience Institute, CHI St. Vincent Infirmary, Little Rock, Arkansas
| | - Chesney S Oravec
- College of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee
| | - Nicholas Rossi
- Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee
| | - Vincent Nguyen
- Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee
| | - Garrett T Venable
- Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee
| | - Jock C Lillard
- Arkansas Neuroscience Institute, CHI St. Vincent Infirmary, Little Rock, Arkansas
| | - Prayash Patel
- Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee
| | - Douglas R Taylor
- Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee
| | - Brandy N Vaughn
- College of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee
| | - Douglas Kondziolka
- Department of Neurosurgery, Massachusetts General Hospital, Boston, Massachusetts
| | - Fred G Barker
- Department of Neurosurgery, New York University Langone Medical Center, New York, New York
| | - L Madison Michael
- Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee
- Semmes Murphey Clinic, Memphis, Tennessee
| | - Paul Klimo
- Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee
- Semmes Murphey Clinic, Memphis, Tennessee
- Le Bonheur Children's Hospital, Memphis, Tennessee
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Madureira Lima J, Galea S. Corporate practices and health: a framework and mechanisms. Global Health 2018; 14:21. [PMID: 29448968 PMCID: PMC5815179 DOI: 10.1186/s12992-018-0336-y] [Citation(s) in RCA: 83] [Impact Index Per Article: 11.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/24/2017] [Accepted: 01/26/2018] [Indexed: 01/12/2023] Open
Abstract
BACKGROUND The Global Burden of Disease estimates that approximately a third of deaths worldwide are attributable to behavioural risk factors that, at their core, have the consumption of unhealthful products and exposures produced by profit driven commercial entities. We use Steven Lukes' three-dimensional view of power to guide the study of the practices deployed by commercial interests to foster the consumption of these commodities. Additionally, we propose a framework to systematically study corporations and other commercial interests as a distal, structural, societal factor that causes disease and injury. Our framework offers a systematic approach to mapping corporate activity, allowing us to anticipate and prevent actions that may have a deleterious effect on population health. CONCLUSION Our framework may be used by, and can have utility for, public health practitioners, researchers, students, activists and other members of civil society, policy makers and public servants in charge of policy implementation. It can also be useful to corporations who are interested in identifying key actions they can take towards improving population health.
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Affiliation(s)
- Joana Madureira Lima
- Department of Sociology, University of Oxford, Manor Rd Building, Manor Road, Oxford, OX1 3UQ, UK.
| | - Sandro Galea
- School of Public Health, Boston University, 715 Albany St, Boston, MA, 02118, USA
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Latten T, Westra D, Angeli F, Paulus A, Struss M, Ruwaard D. Pharmaceutical companies and healthcare providers: Going beyond the gift - An explorative review. PLoS One 2018; 13:e0191856. [PMID: 29414998 PMCID: PMC5802853 DOI: 10.1371/journal.pone.0191856] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/02/2017] [Accepted: 01/12/2018] [Indexed: 11/18/2022] Open
Abstract
INTRODUCTION Interactions between pharmaceutical companies and healthcare providers are increasingly scrutinized by academics, professionals, media, and politicians. Most empirical studies and professional guidelines focus on unilateral donor-recipient types of interaction and overlook, or fail to distinguish between, more reciprocal types of interaction. However, the degree of goal alignment and potential for value creation differs in these two types of interactions. Failing to differentiate between these two forms of interaction between pharmaceutical companies and healthcare providers could thus lead to biased conclusions regarding their desirability. This study reviews the empirical literature regarding the effects of bilateral forms of interactions between pharmaceutical companies and healthcare providers in order to explore their effects. MATERIAL AND METHODS We searched two medical databases (i.e. PubMed and Cochrane Library) and one business database (i.e. EBSCO) for empirical, peer-reviewed articles concerning any type of bilateral interaction between pharmaceutical companies and healthcare providers. We included quantitative articles which were written in English and published between January 1st, 2000 and October 31st, 2016, and where the title or abstract included a combination of synonyms of the following keywords: pharmaceutical companies, healthcare providers, interaction, and effects. RESULTS Our search results yielded 10 studies which were included in our analysis. These studies focused on either research-oriented interaction or on education-oriented interaction. The included studies reported various outcomes of interaction such as prescribing behavior, ethical dilemmas, and research output. Regardless of the type of interaction, the studies either reported no significant effects or ambivalent outcomes such as affected clinical practice or ethical issues. DISCUSSION AND CONCLUSION The effects of bilateral interactions reported in the literature are similar to those reported in studies concerning unilateral interactions. The theoretical notion that bilateral interactions between pharmaceutical companies and healthcare providers have different effects given their increased level of goal alignment thus does not seem to hold. However, most of the empirical studies focus on intermediary, provider-level, outcomes such as altered prescribing behavior. Outcomes at the health system level such as overall costs and quality of care are overlooked. Further research is necessary in order to disentangle various forms of value created by different types of interactions between pharmaceutical companies and healthcare providers.
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Affiliation(s)
- Tom Latten
- Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands
- * E-mail: ,
| | - Daan Westra
- Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands
| | - Federica Angeli
- Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands
- Department of Organization Studies, School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands
| | - Aggie Paulus
- Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands
| | - Marleen Struss
- Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands
| | - Dirk Ruwaard
- Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands
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Barnes RM, Johnston HM, MacKenzie N, Tobin SJ, Taglang CM. The effect of ad hominem attacks on the evaluation of claims promoted by scientists. PLoS One 2018; 13:e0192025. [PMID: 29381757 PMCID: PMC5790247 DOI: 10.1371/journal.pone.0192025] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/01/2017] [Accepted: 01/16/2018] [Indexed: 11/19/2022] Open
Abstract
Two experiments were conducted to determine the relative impact of direct and indirect (ad hominem) attacks on science claims. Four hundred and thirty-nine college students (Experiment 1) and 199 adults (Experiment 2) read a series of science claims and indicated their attitudes towards those claims. Each claim was paired with one of the following: A) a direct attack upon the empirical basis of the science claim B) an ad hominem attack on the scientist who made the claim or C) both. Results indicate that ad hominem attacks may have the same degree of impact as attacks on the empirical basis of the science claims, and that allegations of conflict of interest may be just as influential as allegations of outright fraud.
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Affiliation(s)
- Ralph M. Barnes
- Psychology Department, Montana State University, Bozeman, Montana, United States of America
| | - Heather M. Johnston
- Psychology Department, Columbus State Community College, Columbus, Ohio, United States of America
| | - Noah MacKenzie
- Department of Social Sciences, Clermont College, University of Cincinnati, Batavia, Ohio, United States of America
| | - Stephanie J. Tobin
- School of Psychology, Australian Catholic University, Banyo, Queensland, Australia
| | - Chelsea M. Taglang
- Psychology Department, Hood College, Frederick, Maryland, United States of America
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Diclofenac Potassium in Acute Postoperative Pain and Dysmenorrhoea: Results from Comprehensive Clinical Trial Reports. Pain Res Manag 2018; 2018:9493413. [PMID: 29623148 PMCID: PMC5829436 DOI: 10.1155/2018/9493413] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/02/2017] [Accepted: 09/13/2017] [Indexed: 12/03/2022]
Abstract
We compared the efficacy of diclofenac potassium in unpublished clinical study reports (CSRs) and published reports to examine publication bias, industry bias, and comprehensiveness. Novartis provided CSRs of randomised double-blind trials of diclofenac potassium involving postoperative patients following third molar extraction (3 trials, n=519), gynaecological surgery (3 trials, n=679), and dysmenorrhoea (2 trials, n=711) conducted in 1988–1990. Searches identified published reports of 6 trials. Information from 599/1909 patients was not published; trials with 846/1909 patients were published in a defunct journal. Greater methodological information in CSRs contributed to lesser risk of bias than published trials. Numbers needed to treat (NNT) from CSRs for all six postoperative trials for at least 50% of maximum pain relief over 6 h were 2.2 (95% confidence interval, 1.9–2.6) and 2.1 (1.8–2.4) for 50 and 100 mg diclofenac potassium, respectively. A Cochrane review of published trial data reported NNTs of 2.1 and 1.9, and one comprehensive analysis reported NNTs of 2.2 and 2.1, respectively. All analyses had similar results for patients remedicating within 8 h. No data from dysmenorrhoea CSRs appeared in a Cochrane review. CSRs provide useful information and increase confidence. Stable efficacy estimates with standard study designs reduce the need for updating reviews.
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de la Torre Hernández JM, Edelman ER. De la investigación no clínica a los ensayos y registros clínicos: retos y oportunidades en la investigación biomédica. Rev Esp Cardiol 2017. [DOI: 10.1016/j.recesp.2017.07.017] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/21/2023]
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Ramsey T, Lai W, Svider PF, Hojjat H, Eloy JA, Folbe AJ. Allergen immunotherapy: exploring areas for further inquiry. Int Forum Allergy Rhinol 2017; 7:1127-1134. [PMID: 29024520 DOI: 10.1002/alr.22016] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/24/2017] [Revised: 08/17/2017] [Accepted: 08/28/2017] [Indexed: 12/19/2022]
Abstract
BACKGROUND Allergy-related illness impacts millions of individuals worldwide. Our objectives were to characterize current trends of clinical trials research relating to allergen immunotherapy and to describe the landscape of allergen immunotherapy in National Institutes of Health (NIH)-supported research inquiry. METHODS On ClinicalTrials.gov, the following terms were searched: allergen immunotherapy OR allergy immunotherapy. Variables, including completion status, dates, design, study population, funder, location, and allergen were recorded. The NIH Research Portfolio Online Reporting Tools (RePORTER) system was also used to gather relevant variables. RESULTS A total of 372 clinical trials met inclusion criteria. The proportion of industry-funded clinical trials has declined over 15 years. There has been a slow decline in pollen allergy immunotherapy research, with an increase in both food and animal allergy immunotherapy research. Otolaryngologists comprised only 6.4% of clinical trials principal investigators (PIs). There was a total adjusted NIH funding of $74,986,125 for the 118 total funding years. CONCLUSION Despite an immense interest in allergen immunotherapy, this analysis demonstrates that otolaryngologists represented a small proportion of PIs leading associated clinical trials and basic science inquiry. The proportion of trials with industry sponsorship has declined considerably in recent decades. These trends could help direct future resource allocation for allergen immunotherapy.
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Affiliation(s)
- Tam Ramsey
- Department of Otolaryngology-Head and Neck Surgery, Wayne State University School of Medicine, Detroit, MI
| | - Wanda Lai
- Department of Otolaryngology-Head and Neck Surgery, Wayne State University School of Medicine, Detroit, MI
| | - Peter F Svider
- Department of Otolaryngology-Head and Neck Surgery, Wayne State University School of Medicine, Detroit, MI
| | - Houmehr Hojjat
- Department of Otolaryngology-Head and Neck Surgery, Wayne State University School of Medicine, Detroit, MI
| | - Jean Anderson Eloy
- Department of Otolaryngology-Head and Neck Surgery, Rutgers New Jersey Medical School, Newark, NJ.,Department of Neurological Surgery, Rutgers New Jersey Medical School, Newark, NJ.,Center for Skull Base and Pituitary Surgery, Neurological Institute of New Jersey, Rutgers New Jersey Medical School, Newark, NJ.,Department of Ophthalmology and Visual Science, Rutgers New Jersey Medical School, Newark, NJ
| | - Adam J Folbe
- Department of Otolaryngology, William Beaumont Hospital, Royal Oak, MI
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Abstract
Three decades after the discovery of prions as the cause of Creutzfeldt-Jakob disease and other transmissible spongiform encephalopathies, we are still nowhere close to finding an effective therapy. Numerous pharmacological interventions have attempted to target various stages of disease progression, yet none has significantly ameliorated the course of disease. We still lack a mechanistic understanding of how the prions damage the brain, and this situation results in a dearth of validated pharmacological targets. In this review, we discuss the attempts to interfere with the replication of prions and to enhance their clearance. We also trace some of the possibilities to identify novel targets that may arise with increasing insights into prion biology.
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Affiliation(s)
- Adriano Aguzzi
- Institute of Neuropathology, University of Zurich, CH-8091 Zürich, Switzerland;
| | - Asvin K K Lakkaraju
- Institute of Neuropathology, University of Zurich, CH-8091 Zürich, Switzerland;
| | - Karl Frontzek
- Institute of Neuropathology, University of Zurich, CH-8091 Zürich, Switzerland;
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From Nonclinical Research to Clinical Trials and Patient-registries: Challenges and Opportunities in Biomedical Research. ACTA ACUST UNITED AC 2017; 70:1121-1133. [PMID: 28838647 DOI: 10.1016/j.rec.2017.07.008] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/12/2017] [Accepted: 07/18/2017] [Indexed: 12/13/2022]
Abstract
The most important challenge faced by human beings is health. The only way to provide better solutions for health care is innovation, true innovation. The only source of true innovation is research, good research indeed. The pathway from a basic science study to a randomized clinical trial is long and not free of bumps and even landmines. These are all the obstacles and barriers that limit the availability of resources, entangle administrative-regulatory processes, and restrain investigators' initiatives. There is increasing demand for evidence to guide clinical practice but, paradoxically, biomedical research has become increasingly complex, expensive, and difficult to integrate into clinical care with increased barriers to performing the practical aspects of investigation. We face the challenge of increasing the volume of biomedical research and simultaneously improving the efficiency and output of this research. In this article, we review the main stages and methods of biomedical research, from nonclinical studies with animal and computational models to randomized trials and clinical registries, focusing on their limitations and challenges, but also providing alternative solutions to overcome them. Fortunately, challenges are always opportunities in disguise.
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Bandari J, Jacobs BL. Editorial Commentary. UROLOGY PRACTICE 2017; 4:347. [PMID: 28775999 PMCID: PMC5538307 DOI: 10.1016/j.urpr.2016.07.016] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Affiliation(s)
- Jathin Bandari
- Department of Urology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
| | - Bruce L. Jacobs
- Department of Urology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
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Narain AS, Hijji FY, Yom KH, Kudaravalli KT, Singh K. Cervical disc arthroplasty: do conflicts of interest influence the outcome of clinical studies? Spine J 2017; 17:1026-1032. [PMID: 28343045 DOI: 10.1016/j.spinee.2017.03.018] [Citation(s) in RCA: 24] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/06/2016] [Revised: 02/10/2017] [Accepted: 03/20/2017] [Indexed: 02/03/2023]
Abstract
BACKGROUND CONTEXT Cervical disc arthroplasty (CDA) is an emerging technique for the treatment of cervical degenerative disease. Multiple studies have investigated the outcomes of CDA, particularly in comparison with cervical arthrodesis techniques such as anterior cervical discectomy and fusion (ACDF). As many entities have financial interests in CDA implants, it is imperative to consider the influence of conflicts of interest on the results of studies investigating the efficacy of CDA. PURPOSE This study aimed to determine if there is an association between the presence of conflicts of interest among study authors and the reported outcome of studies involving CDA. STUDY DESIGN This is a systematic review of clinical CDA publications until October 2016. OUTCOME MEASURE The outcome measures are presence of conflicts of interest, level of evidence, and outcome for all included studies. METHODS PubMed and MEDLINE databases were searched for articles presenting clinical, radiographic, and cost outcomes of CDA. Data extracted from each article included title, authors, publication year, level of evidence, prosthesis type, number of operative levels, presence of conflicts of interest, and outcome. Conflicts of interest were determined by the presence of any conflicts for any author within manuscript disclosure sections or through Open Payments reporting. Outcomes of each study were graded as either favorable, unfavorable, or equivocal. The presence of conflicts of interest was tested for an association with the level of evidence and study outcome using Pearson chi-square analysis, Fisher exact test, or logistic regression for categorical variables. The authors report no conflicts of interest directly related to this work, and have not received any funds in support of this work. RESULTS A total of 98 articles were included in this analysis. In total, 44.9% (44) of articles had the presence of a conflict of interest, whereas 55.1% (54) of articles did not. Conflicted studies were more likely to present level I evidence and less likely to present level IV evidence than non-conflicted studies (p<.001). Furthermore, conflicted studies were more likely to report favorable outcomes after CDA than non-conflicted studies (90.9% vs. 74.1%, p=.040). CONCLUSIONS The results of this study suggest that the majority of conflicted and non-conflicted studies report favorable results in patients undergoing CDA. However, conflicted studies were also more likely to report favorable outcomes compared with non-conflicted studies. Individual clinicians must critically review published studies for potential conflicts of interest before incorporating CDA into their practice.
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Affiliation(s)
- Ankur S Narain
- Department of Orthopedic Surgery, Rush University Medical Center, 1611 W. Harrison St, Suite #300, Chicago, IL 60612, USA
| | - Fady Y Hijji
- Department of Orthopedic Surgery, Rush University Medical Center, 1611 W. Harrison St, Suite #300, Chicago, IL 60612, USA
| | - Kelly H Yom
- Department of Orthopedic Surgery, Rush University Medical Center, 1611 W. Harrison St, Suite #300, Chicago, IL 60612, USA
| | - Krishna T Kudaravalli
- Department of Orthopedic Surgery, Rush University Medical Center, 1611 W. Harrison St, Suite #300, Chicago, IL 60612, USA
| | - Kern Singh
- Department of Orthopedic Surgery, Rush University Medical Center, 1611 W. Harrison St, Suite #300, Chicago, IL 60612, USA.
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Tarkang EE, Kweku M, Zotor FB. Publication Practices and Responsible Authorship: A Review Article. J Public Health Afr 2017; 8:723. [PMID: 28748064 PMCID: PMC5510206 DOI: 10.4081/jphia.2017.723] [Citation(s) in RCA: 28] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/10/2017] [Accepted: 06/16/2017] [Indexed: 11/23/2022] Open
Abstract
Dissemination of research findings through the publication of one's work or a group of contributors is an important part of the research process, as this allows the passing on of benefits to a much wider community. In whatever evocative form this dissemination may take, the onus lies on the author(s) to ensure adherence to the code of ethics as it pertains to the integrity of the information being put out. We publish because we want our findings to be adapted into practice and application, or in some cases may be relevant to policy makers in decision-making. To a large extent in the field of academia, successful publication improves opportunities for academic funding and promotion whilst enhancing scientific and scholarly achievement and repute. A situation may be compromised where intellectual contributions to a scientific investigation do not adhere to the four key guidelines of scholarship, authorship, approval and agreement as well as the protocols of ensuring good publication ethics. The objective of this review is to lay emphasis on universal standards for manuscript authorship and to fostering good practices. This in our view will bring authorship credit and accountability to the attention of our colleagues and readers at large. To achieve this, a systematic and critical review of the literature was undertaken. Electronic databases, academic journals and books from various sources were accessed. Several key search terms relating to responsible authorship, common authorship malpractices, conflict of interest, universal publication guidelines and other authorship related issues, were used. Only references deemed useful from relevant texts and journal articles were included. In this paper, the authors have sought to highlight the pitfalls researchers sometimes entangle themselves within an act of compromise thereby impinging on the ethical and professional responsibilities for the content of a paper under consideration. This article presents the case that authorship has a strong currency that brings not only personal satisfaction but also career rewards based on publication counting. In all cases described here, a universal standard for manuscript authorship will be critical in fostering good practices. As you write and review manuscripts, keep these good practices in mind, and consider ways to bring authorship credit and accountability to the attention of your colleagues and readers.
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Affiliation(s)
- Elvis E. Tarkang
- Department of Population and Behavioural Sciences, School of Public Health, University of Health and Allied Sciences, Ho, Ghana
- HIV/AIDS Prevention Research Network, Kumba, Cameroon
| | - Margaret Kweku
- Departments of Epidemiology and Biostatistics, School of Public Health, University of Health and Allied Sciences, Ghana
| | - Francis B. Zotor
- Departments of Family and Community Health, School of Public Health, University of Health and Allied Sciences, Ghana
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