Index of the human papillomavirus (HPV) vaccine industry clinical study programmes and non-industry funded studies: a necessary basis to address reporting bias in a systematic review.
ABSTRACT: Unabridged access to drug industry and regulatory trial registers and data reduces reporting bias in systematic reviews and may provide a complete index of a drug's clinical study programme. Currently, there is no public index of the human papillomavirus (HPV) vaccine industry study programmes or a public index of non-industry funded studies.By cross-verification via study programme enquiries to the HPV vaccine manufacturers and regulators and searches of trial registers and journal publication databases, we indexed clinical HPV vaccine studies as a basis to address reporting bias in a systematic review of clinical study reports.We indexed 206 clinical studies: 145 industry and 61 non-industry funded studies. One of the four HPV vaccine manufacturers (GlaxoSmithKline) provided information on its study programme. Most studies were cross-verified from two or more sources (160/206, 78%) and listed on regulatory or industry trial registers or journal publication databases (195/206, 95%)-in particular, on ClinicalTrials.gov (176/195, 90%). However, study results were only posted for about half of the completed studies on ClinicalTrials.gov (71/147, 48%). Two thirds of the industry studies had a study programme ID, manufacturer specific ID, and national clinical trial (NCT) ID (91/145, 63%). Journal publications were available in journal publication databases (the Cochrane Collaboration's Central Register of Controlled Trials, Google Scholar and PubMed) for two thirds of the completed studies (92/149, 62%).We believe we came close to indexing complete HPV vaccine study programmes, but only one of the four manufacturers provided information for our index and a fifth of the index could not be cross-verified. However, we indexed larger study programmes than those listed by major regulators (i.e., the EMA and FDA that based their HPV vaccine approvals on only half of the available trials). To reduce reporting bias in systematic reviews, we advocate the registration and publication of all studies and data in the public domain.
Project description:To assess the time to publication of primary research and evidence syntheses funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme published as a monograph in Health Technology Assessment and as a journal article in the wider biomedical literature.Retrospective cohort study.Primary research and evidence synthesis projects funded by the HTA Programme were included in the cohort if they were registered in the NIHR research programmes database and was planned to submit the draft final report for publication in Health Technology Assessment on or before 9 December 2011.The median time to publication and publication at 30 months in Health Technology Assessment and in an external journal were determined by searching the NIHR research programmes database and HTA Programme website.Of 458 included projects, 184 (40.2%) were primary research projects and 274 (59.8%) were evidence syntheses. A total of 155 primary research projects had a completion date; the median time to publication was 23 months (26.5 and 35.5 months to publish a monograph and to publish in an external journal, respectively) and 69% were published within 30 months. The median time to publication of HTA-funded trials (n=126) was 24 months and 67.5% were published within 30 months. Among the evidence syntheses with a protocol online date (n=223), the median time to publication was 25.5 months (28 months to publication as a monograph), but only 44.4% of evidence synthesis projects were published in an external journal. 65% of evidence synthesis studies had been published within 30.0 months.Research funded by the HTA Programme publishes promptly. The importance of Health Technology Assessment was highlighted as the median time to publication was 9 months shorter for a monograph than an external journal article.
Project description:This data aimed to audit the articles retracted from PubMed indexed dental journals from India. The PubMed indexed journals considered are Indian Journal of Dental research, Journal of Indian Society of Periodontology, Contemporary Clinical Dentistry, Journal of Indian Society of Pedodontics and Preventive Dentistry, Journal of Oral and Maxillofacial Pathology and Journal of Indian Prosthodontic Society for type of article, name of dental specialty, topic of individual dental specialties, causes for retraction of article and authorship trend of retracted articles using web-based search. Among PubMed indexed Indian dental journals,the number of retracted articles were as follows: Indian Journal of Dental research (4) followed by Journal of Indian Society of Periodontology (3), Contemporary Clinical Dentistry (3), Journal of Indian Society of Pedodontics and Preventive Dentistry (2), Journal of Oral and Maxillofacial Pathology (2) and Journal of Indian Prosthodontic Society (1). Out of 15 retracted articles from PubMed indexed Indian dental journals, case reports (7) form a major share followed by original articles(6) and review articles (2). Among the dental specialties of retracted articles, oral pathology and microbiology (5) constitute the major share followed by periodontics (4), pedodontics (4), oral medicine and radiology (1) and prosthodontics (1). Duplicate publication (7), plagiarism (5) and authorship dispute (3) are the causes for the retraction of article.
Project description:BACKGROUND:Predatory journals fail to fulfill the tenets of biomedical publication: peer review, circulation, and access in perpetuity. Despite increasing attention in the lay and scientific press, no studies have directly assessed the perceptions of the authors or editors involved. OBJECTIVE:Our objective was to understand the motivation of authors in sending their work to potentially predatory journals. Moreover, we aimed to understand the perspective of journal editors at journals cited as potentially predatory. METHODS:Potential online predatory journals were randomly selected among 350 publishers and their 2204 biomedical journals. Author and editor email information was valid for 2227 total potential participants. A survey for authors and editors was created in an iterative fashion and distributed. Surveys assessed attitudes and knowledge about predatory publishing. Narrative comments were invited. RESULTS:A total of 249 complete survey responses were analyzed. A total of 40% of editors (17/43) surveyed were not aware that they were listed as an editor for the particular journal in question. A total of 21.8% of authors (45/206) confirmed a lack of peer review. Whereas 77% (33/43) of all surveyed editors were at least somewhat familiar with predatory journals, only 33.0% of authors (68/206) were somewhat familiar with them (P<.001). Only 26.2% of authors (54/206) were aware of Beall's list of predatory journals versus 49% (21/43) of editors (P<.001). A total of 30.1% of authors (62/206) believed their publication was published in a predatory journal. After defining predatory publishing, 87.9% of authors (181/206) surveyed would not publish in the same journal in the future. CONCLUSIONS:Authors publishing in suspected predatory journals are alarmingly uninformed in terms of predatory journal quality and practices. Editors' increased familiarity with predatory publishing did little to prevent their unwitting listing as editors. Some suspected predatory journals did provide services akin to open access publication. Education, research mentorship, and a realignment of research incentives may decrease the impact of predatory publishing.
Project description:BACKGROUND: transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals. We investigated industry-supported trials' influence on journal impact factors and revenue. METHODS AND FINDINGS: we sampled six major medical journals (Annals of Internal Medicine, Archives of Internal Medicine, BMJ, JAMA, The Lancet, and New England Journal of Medicine [NEJM]). For each journal, we identified randomised trials published in 1996-1997 and 2005-2006 using PubMed, and categorized the type of financial support. Using Web of Science, we investigated citations of industry-supported trials and the influence on journal impact factors over a ten-year period. We contacted journal editors and retrieved tax information on income from industry sources. The proportion of trials with sole industry support varied between journals, from 7% in BMJ to 32% in NEJM in 2005-2006. Industry-supported trials were more frequently cited than trials with other types of support, and omitting them from the impact factor calculation decreased journal impact factors. The decrease varied considerably between journals, with 1% for BMJ to 15% for NEJM in 2007. For the two journals disclosing data, income from the sales of reprints contributed to 3% and 41% of the total income for BMJ and The Lancet in 2005-2006. CONCLUSIONS: publication of industry-supported trials was associated with an increase in journal impact factors. Sales of reprints may provide a substantial income. We suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals' revenue and impact.
Project description:The lack of applied scientific research on camels, despite them being recognized as production animals, compels the reorganization of emerging camel breeding systems with the aim of achieving successful camel welfare management strategies all over the world. Relevant and properly-framed research widely impacts dissemination of scientific contents and drives public willingness to enhance ethically acceptable conditions for domestic animals. Consumer perception of this livestock industry will improve and high-quality products will be obtained. This paper draws on bibliometric indicators as promoting factors for camel-related research advances, tracing historical scientific publications indexed in ScienceDirect directory from 1880-2019. Camel as a species did not affect Journal Citation Reports (JCR) impact (p > 0.05) despite the journal, author number, corresponding author origin, discipline and publication year affecting it (p < 0.001). Countries with traditionally well-established camel farming are also responsible for the papers with the highest academic impact. However, camel research advances may have only locally and partially influenced welfare related laws, so intentional harming acts and basic needs neglect may persist in these species. A sustainable camel industry requires those involved in camel research to influence business stakeholders and animal welfare advocacies by highlighting the benefits of camel wellbeing promotion, co-innovation partnership establishment and urgent enhancement of policy reform.
Project description:Sub-Saharan Africa bears the greatest burden of cervical cancer. Human papillomavirus (HPV) vaccination programmes to prevent the disease will need to reach vulnerable girls who may not be able access health and screening services in the future. We conducted formative research on facilitators and barriers to HPV vaccination and potential acceptability of a future HPV vaccination programme amongst girls living in hard-to-reach populations in Kenya.Stakeholder interviews with Ministry of Health staff explored barriers to and support for the uptake of HPV vaccination. A situation assessment was conducted to assess community services in Maasai nomadic pastoralist communities in Kajiado County and in Korogocho informal settlement in Nairobi city, followed by focus group discussions (n=14) and semi-structured interviews (n=28) with health workers, parents, youth, and community and religious leaders. These covered marriage, knowledge of cervical cancer and HPV, factors that might inhibit or support HPV vaccine uptake and intention to accept HPV vaccine if a programme was in place.Reported challenges to an HPV vaccination programme included school absenteeism and drop-out, early age of sex and marriage, lack of parental support, population mobility and distance from services. Despite little prior knowledge of cervical cancer and HPV, communities were interested in receiving HPV vaccination. Adequate social mobilisation and school-based vaccination, supplemented by out-reach activities, were considered important facilitating factors to achieve high coverage. There was some support for a campaign approach to vaccine delivery.Given the high level of support for a vaccine against cervical cancer and the experience of reaching pastoralist and slum-dwellers for other immunizations, implementing an HPV vaccine programme should be feasible in such hard-to-reach communities. This may require additional delivery strategies in addition to the standard school-based delivery, with vaccine offered at multiple venues, potentially through a campaign approach.
Project description:In 2008, a national human papillomavirus (HPV) immunisation programme began in Scotland for 12-13 year old females with a three-year catch-up campaign for those under the age of 18. Since 2008, three-dose uptake of bivalent vaccine in the routine cohort aged 12-13 has exceeded 90% annually, while in the catch-up cohort overall uptake is 66%.To monitor the impact of HPV immunisation, a programme of national surveillance was established (pre and post introduction) which included yearly sampling and HPV genotyping of women attending for cervical screening at age 20. By linking individual vaccination, screening and HPV testing records, we aim to determine the impact of the immunisation programme on circulating type-specific HPV infection particularly for four outcomes: (i) the vaccine types HPV 16 or 18 (ii) types considered to be associated with cross-protection: HPV 31, 33 or 45; (iii) all other high-risk types and (iv) any HPV.From a total of 4679 samples tested, we demonstrate that three doses (n=1100) of bivalent vaccine are associated with a significant reduction in prevalence of HPV 16 and 18 from 29.8% (95% confidence interval 28.3, 31.3%) to 13.6% (95% confidence interval 11.7, 15.8%). The data also suggest cross-protection against HPV 31, 33 and 45. HPV 51 and 56 emerged as the most prevalent (10.5% and 9.6%, respectively) non-vaccine high-risk types in those vaccinated, but at lower rates than HPV 16 (25.9%) in those unvaccinated.This data demonstrate the positive impact of bivalent vaccination on the prevalence of HPV 16, 18, 31, 33 and 45 in the target population and is encouraging for countries which have achieved high-vaccine uptake.
Project description:The aim was to investigate school nurses' attitudes towards, and experiences of vaccination against human papillomavirus (HPV), and compare the results with a similar study three years earlier. School nurses (n = 736) from all counties in Sweden completed a questionnaire in spring 2016, four years after the implementation of the national HPV vaccination programme, and three years after the previous survey. Overall, the school nurses had more favourable attitudes towards the HPV vaccination programme compared to the study in 2013 (p = 0.015). More than half of the nurses (n = 415, 56%) strongly agreed that boys should also be offered the vaccine (p<0.001). There were no differences in school nurses' perceived knowledge about HPV in order to inform and to answer questions about the vaccine from the girls or from the parents. More than half of the nurses (n = 409, 56%) reported that they needed more education about HPV. Almost all nurses (n = 659, 90%) had been contacted by parents with questions about the vaccine, and most questions were related to vaccine safety. School nurses have a more favourable attitude towards the vaccination programme against HPV compared to three years earlier, although almost all nurses had been contacted by parents with diverse questions and concerns. The nurses believed that they needed more education about HPV. Thus, it is essential to provide ongoing education and training for school nurses who are key healthcare professionals for providing information about HPV and HPV vaccination to parents and to pupils.
Project description:BACKGROUND:Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. METHODS AND FINDINGS:We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. CONCLUSIONS:Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol.
Project description:The Infectious Diseases of Poverty journal, launched a year ago, is a platform to engage outside the traditional disciplinary boundaries, and disseminate high quality science towards the improvement of health. This paper reviews the milestone achievements during its first year of operation. The journal has filled an important niche, addressing some of the main priorities in the Global Report for Research on Infectious Diseases of Poverty. Highlights include the publication of three thematic issues on health systems, surveillance and response systems, as well as co-infection and syndemics. The thematic issues have foregrounded the importance and innovation that can be achieved through transdisciplinary research. The journal has been indexed by PubMed since April 2013, with the publication of a total of 38 articles. Finally, the journal is delivering to wider range readers both in developing and developed countries with sustained efforts with a focus on relevant and strategic information towards elimination of infectious diseases of poverty.