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1.  Strategies for Managing Multi-Sponsored Core Facilities: How do you make “everyone” your first priority? 
FLOW CYTOMETRY SHARED RESOURCE: The VMC FCSR offers a myriad of flow cytometry and immunology related services and support to multiple supporting Centers, Veterans Administration scientist, and external private entities and of course the Vanderbilt research community at large. Users range from undergraduates all the way up to and including Principle Investigators. Every effort is made to tailor each individual's support to his or her specific needs and experience with consideration given to Institution/Center/Department/Lab membership. Prioritizing members of a group that provides sponsorship to our shared resource while maintaining a high standard of customer service and technological support to all members can be challenging, but accomplished with foresight, good communication and transparency in the process. One of the keys for success is a good strategy to ensure adequate capacity for all users, while highlighting support for specific sponsored members whenever relevant. A resource or capacity starved service Core will constantly be struggling to provide acceptable support to a sponsoring group while maintaining customer service standards and meeting the scientific needs of the broader user base. Accurate accounting of each sponsoring groups usage contrasted with the usage of all others is a good way to measure and prioritize changing needs that your core must address. If such metrics can be presented to governing bodies and sponsoring parties at our institution, planning ahead for the acquisition of additional resources or personal before they become critical becomes manageable. Targeted support or new resources that may initially only be pertinent to an individual sponsoring group will generally lead to greater use by the entire user base once successful results are reported by the focused, sponsored group. We have found the implementation of a Scientific Advisory Board comprised of members of supporting Centers and a diverse representation of our general user base to be critical to providing the service and support we strive for. An advising body that can provide a platform to display our Core finances, usage and capacity transparently and allow users at different levels to gain insight on the realities we face and assist us in making decisions is extremely helpful. In a collegial environment such as this consensus can be reached and concerns can be voiced that allow us to continue to support all users at the highest possible level. Each board member can then return to their home department and relay their findings back to their colleagues, which leads to greater overall acceptance and understanding by all. Lastly, oversight by a strong institutional leadership body with broad vision that encompasses all of the sponsoring groups and users has been critical to meet these challenges.
PMCID: PMC3635429
2.  Factors Associated with Findings of Published Trials of Drug–Drug Comparisons: Why Some Statins Appear More Efficacious than Others 
PLoS Medicine  2007;4(6):e184.
Background
Published pharmaceutical industry–sponsored trials are more likely than non-industry-sponsored trials to report results and conclusions that favor drug over placebo. Little is known about potential biases in drug–drug comparisons. This study examined associations between research funding source, study design characteristics aimed at reducing bias, and other factors that potentially influence results and conclusions in randomized controlled trials (RCTs) of statin–drug comparisons.
Methods and Findings
This is a cross-sectional study of 192 published RCTs comparing a statin drug to another statin drug or non-statin drug. Data on concealment of allocation, selection bias, blinding, sample size, disclosed funding source, financial ties of authors, results for primary outcomes, and author conclusions were extracted by two coders (weighted kappa 0.80 to 0.97). Univariate and multivariate logistic regression identified associations between independent variables and favorable results and conclusions. Of the RCTs, 50% (95/192) were funded by industry, and 37% (70/192) did not disclose any funding source. Looking at the totality of available evidence, we found that almost all studies (98%, 189/192) used only surrogate outcome measures. Moreover, study design weaknesses common to published statin–drug comparisons included inadequate blinding, lack of concealment of allocation, poor follow-up, and lack of intention-to-treat analyses. In multivariate analysis of the full sample, trials with adequate blinding were less likely to report results favoring the test drug, and sample size was associated with favorable conclusions when controlling for other factors. In multivariate analysis of industry-funded RCTs, funding from the test drug company was associated with results (odds ratio = 20.16 [95% confidence interval 4.37–92.98], p < 0.001) and conclusions (odds ratio = 34.55 [95% confidence interval 7.09–168.4], p < 0.001) that favor the test drug when controlling for other factors. Studies with adequate blinding were less likely to report statistically significant results favoring the test drug.
Conclusions
RCTs of head-to-head comparisons of statins with other drugs are more likely to report results and conclusions favoring the sponsor's product compared to the comparator drug. This bias in drug–drug comparison trials should be considered when making decisions regarding drug choice.
Lisa Bero and colleagues found published trials comparing one statin with another were more likely to report results and conclusions favoring the sponsor's product than the comparison drug.
Editors' Summary
Background.
Randomized controlled trials are generally considered to be the most reliable type of experimental study for evaluating the effectiveness of different treatments. Randomization involves the assignment of participants in the trial to different treatment groups by the play of chance. Properly done, this procedure means that the different groups are comparable at outset, reducing the chance that outside factors could be responsible for treatment effects seen in the trial. When done properly, randomization also ensures that the clinicians recruiting participants into the trial cannot know the treatment group to which a patient will end up being assigned. However, despite these advantages, a large number of factors can still result in bias creeping in. Bias comes about when the findings of research appear to differ in some systematic way from the true result. Other research studies have suggested that funding is a source of bias; studies sponsored by drug companies seem to more often favor the sponsor's drug than trials not sponsored by drug companies
Why Was This Study Done?
The researchers wanted to more precisely understand the impact of different possible sources of bias in the findings of randomized controlled trials. In particular, they wanted to study the outcomes of “head-to-head” drug comparison studies for one particular class of drugs, the statins. Drugs in this class are commonly prescribed to reduce the levels of cholesterol in blood amongst people who are at risk of heart and other types of disease. This drug class is a good example for studying the role of bias in drug–drug comparison trials, because these trials are extensively used in decision making by health-policy makers.
What Did the Researchers Do and Find?
This research study was based on searching PubMed, a biomedical literature database, with the aim of finding all randomized controlled trials of statins carried out between January 1999 and May 2005 (reference lists also were searched). Only trials which compared one statin to another statin or one statin to another type of drug were included. The researchers extracted the following information from each article: the study's source of funding, aspects of study design, the overall results, and the authors' conclusions. The results were categorized to show whether the findings were favorable to the test drug (the newer statin), inconclusive, or not favorable to the test drug. Aspects of each study's design were also categorized in relation to various features, such as how well the randomization was done (in particular, the degree to which the processes used would have prevented physicians from knowing which treatment a patient was likely to receive on enrollment); whether all participants enrolled in the trial were eventually analyzed; and whether investigators or participants knew what treatment an individual was receiving.
One hundred and ninety-two trials were included in this study, and of these, 95 declared drug company funding; 23 declared government or other nonprofit funding while 74 did not declare funding or were not funded. Trials that were properly blinded (where participants and investigators did not know what treatment an individual received) were less likely to have conclusions favoring the test drug. However, large trials were more likely to favor the test drug than smaller trials. When looking specifically at the trials funded by drug companies, the researchers found various factors that predicted whether a result or conclusion favored the test drug. These included the impact of the journal publishing the results; the size of the trial; and whether funding came from the maker of the test drug. However, properly blinded trials were less likely to produce results favoring the test drug. Even once all other factors were accounted for, the funding source for the study was still linked with results and conclusions that favored the maker of the test drug.
What Do These Findings Mean?
This study shows that the type of sponsorship available for randomized controlled trials of statins was strongly linked to the results and conclusions of those studies, even when other factors were taken into account. However, it is not clear from this study why sponsorship has such a strong link to the overall findings. There are many possible reasons why this might be. Some people have suggested that drug companies may deliberately choose lower dosages for the comparison drug when they carry out “head-to-head” trials; this tactic is likely to result in the company's product doing better in the trial. Others have suggested that trials which produce unfavorable results are not published, or that unfavorable outcomes are suppressed. Whatever the reasons for these findings, the implications are important, and suggest that the evidence base relating to statins may be substantially biased.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040184.
The James Lind Library has been created to help people understand fair tests of treatments in health care by illustrating how fair tests have developed over the centuries
The International Committee of Medical Journal Editors has provided guidance regarding sponsorship, authorship, and accountability
The CONSORT statement is a research tool that provides an evidence-based approach for reporting the results of randomized controlled trials
Good Publication Practice guidelines provide standards for responsible publication of research sponsored by pharmaceutical companies
Information from Wikipedia on Statins. Wikipedia is an internet encyclopedia anyone can edit
doi:10.1371/journal.pmed.0040184
PMCID: PMC1885451  PMID: 17550302
3.  Financial Conflicts of Interest and Reporting Bias Regarding the Association between Sugar-Sweetened Beverages and Weight Gain: A Systematic Review of Systematic Reviews 
PLoS Medicine  2013;10(12):e1001578.
Maira Bes-Rastrollo and colleagues examine whether financial conflicts of interest are likely to bias conclusions from systematic reviews that investigate the relationship between sugar-sweetened beverages and weight gain or obesity.
Please see later in the article for the Editors' Summary
Background
Industry sponsors' financial interests might bias the conclusions of scientific research. We examined whether financial industry funding or the disclosure of potential conflicts of interest influenced the results of published systematic reviews (SRs) conducted in the field of sugar-sweetened beverages (SSBs) and weight gain or obesity.
Methods and Findings
We conducted a search of the PubMed, Cochrane Library, and Scopus databases to identify published SRs from the inception of the databases to August 31, 2013, on the association between SSB consumption and weight gain or obesity. SR conclusions were independently classified by two researchers into two groups: those that found a positive association and those that did not. These two reviewers were blinded with respect to the stated source of funding and the disclosure of conflicts of interest.
We identified 17 SRs (with 18 conclusions). In six of the SRs a financial conflict of interest with some food industry was disclosed. Among those reviews without any reported conflict of interest, 83.3% of the conclusions (10/12) were that SSB consumption could be a potential risk factor for weight gain. In contrast, the same percentage of conclusions, 83.3% (5/6), of those SRs disclosing some financial conflict of interest with the food industry were that the scientific evidence was insufficient to support a positive association between SSB consumption and weight gain or obesity. Those reviews with conflicts of interest were five times more likely to present a conclusion of no positive association than those without them (relative risk: 5.0, 95% CI: 1.3–19.3).
An important limitation of this study is the impossibility of ruling out the existence of publication bias among those studies not declaring any conflict of interest. However, the best large randomized trials also support a direct association between SSB consumption and weight gain or obesity.
Conclusions
Financial conflicts of interest may bias conclusions from SRs on SSB consumption and weight gain or obesity.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In our daily lives, we frequently rely on the results of scientific research to make decisions about our health. If we are healthy, we may seek out scientific advice about how much exercise to do to reduce our risk of a heart attack, and we may follow dietary advice issued by public health bodies to help us maintain a healthy weight. If we are ill, we expect our treatment to be based on the results of clinical trials and other studies. We assume that the scientific research that underlies our decisions about health-related issues is unbiased and accurate. However, there is increasing evidence that the conclusions of industry-sponsored scientific research are sometimes biased. So, for example, reports of drug trials sponsored by pharmaceutical companies sometimes emphasize the positive results of trials and “hide” unwanted side effects deep within the report or omit them altogether.
Why Was This Study Done?
Although the effects of company sponsors on the conclusions of pharmaceutical research have been extensively examined, little is known about the effects of industry sponsorship on nutrition research, even though large commercial entities are increasingly involved in global food and drink production. It is important to know whether the scientific evidence about nutrition is free of bias because biased information might negatively affect the health of entire populations. Moreover, scientific evidence from nutrition research underlies the formulation of governmental dietary guidelines and food-related public health interventions. In this systematic review, the researchers investigate whether the disclosure of potential financial conflicts of interest (for example, research funding by a beverage company) has influenced the results of systematic reviews undertaken to examine the association between the consumption of highly lucrative sugar-sweetened beverages (SSBs) and weight gain or obesity. Systematic reviews identify all the research on a given topic using predefined criteria. In an ideal world, systematic reviews provide access to all the available evidence on specific exposure–disease associations, but publication bias related to authors' conflicts of interest may affect the reliability of the conclusions of such studies.
What Did the Researchers Do and Find?
The researchers identified 18 conclusions from 17 systematic reviews that had investigated the association between SSB consumption and weight gain or obesity. In six of these reviews, a financial conflict of interest with a food industry was disclosed. Among the reviews that reported having no conflict of interest, 83.3% of the conclusions were that SSB consumption could be a potential risk factor for weight gain. By contrast, the same percentage of reviews in which a potential financial conflict of interest was disclosed concluded that the scientific evidence was insufficient to support a positive association between SSB consumption and weight gain, or reported contradictory results and did not state any definitive conclusion about the association between SSB consumption and weight gain. Reviews in which a potential conflict of interest was disclosed were five times more likely to present a conclusion of no positive association between SSB consumption and weight gain than reviews that reported having no financial conflict of interest.
What Do These Findings Mean?
These findings indicate that systematic reviews that reported financial conflicts of interest or sponsorship from food or drink companies were more likely to reach a conclusion of no positive association between SSB consumption and weight gain than reviews that reported having no conflicts of interest. A major limitation of this study is that it cannot assess which interpretation of the available evidence is truly accurate. For example, the scientists involved in the systematic reviews that reported having no conflict of interest may have had preexisting prejudices that affected their interpretation of their findings. However, the interests of the food industry (increased sales of their products) are very different from those of most researchers (the honest pursuit of knowledge), and recent randomized trials support a positive association between SSB consumption and overweight/obesity. Thus, these findings draw attention to possible inaccuracies in scientific evidence from research funded by the food and drink industry. They do not imply that industry sponsorship of nutrition research should be avoided entirely. Rather, as in other research areas, clear guidelines and principles (for example, sponsors should sign contracts that state that they will not be involved in the interpretation of results) need to be established to avoid dangerous conflicts of interest.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001578.
The Research Ethics Program at the University of California, San Diego provides an overview of conflicts of interest for researchers and details of US regulations and guidelines
The PLOS Medicine series on Big Food examines the activities and influence of the food industry in global health
A PLOS Medicine Research Article by Basu et al. uses mathematical modeling to investigate whether SSB taxation would avert obesity and diabetes in India
A 2012 policy brief from the Yale Rudd Center for Food Policy and Obesity discusses current evidence regarding SSB taxes
The US National Institutes of Health has regulations on financial conflicts of interest for institutions applying to receive funding
Wikipedia has pages on conflict of interest, reporting bias, systematic review, and SSBs (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
doi:10.1371/journal.pmed.1001578
PMCID: PMC3876974  PMID: 24391479
4.  Funding sources for continuing medical education: An observational study 
Aims:
Medical accreditation bodies and licensing authorities are increasingly mandating continuing medical education (CME) credits for maintenance of licensure of healthcare providers. However, the costs involved in participating in these CME activities are often substantial and may be a major deterrent in obtaining these mandatory credits. It is assumed that healthcare providers often obtain sponsorship from their institutions or third party payers (i.e. pharmaceutical-industry) to attend these educational activities. Data currently does not exist exploring the funding sources for CME activities in India. In this study, we examine the relative proportion of CME activities sponsored by self, institution and the pharmaceutical-industry. We also wanted to explore the characteristics of courses that have a high proportion of self-sponsorship.
Materials and Methods:
This is a retrospective audit of the data during the year 2009 conducted at an autonomous clinical training academy. The details of the sponsor of each CME activity were collected from an existing database. Participants were subsequently categorized as sponsored by self, sponsored by institution or sponsored by pharmaceutical-industry.
Results:
In the year 2009, a total of 2235 participants attended 40 different CME activities at the training academy. Of the total participants, 881 (39.4%) were sponsored by self, 898 (40.2%) were sponsored by institution and 456 (20.3%) by pharmaceutical-industry. About 47.8% participants attended courses that carried an international accreditation. For the courses that offer international accreditation, 63.3% were sponsored by self, 34.9% were sponsored by institution and 1.6% were sponsored by pharmaceutical-industry. There were 126 participants (5.6%) who returned to the academy for another CME activity during the study period. Self-sponsored (SS) candidates were more likely to sponsor themselves again for subsequent CME activity compared with the other two groups (P < 0.001).
Conclusions:
In our study, majority of healthcare professionals attending CME activities were either self or institution sponsored. There was a greater inclination for self-sponsoring for activities with international accreditation. SS candidates were more likely to sponsor themselves again for subsequent CME activities.
doi:10.4103/0972-5229.138152
PMCID: PMC4134625  PMID: 25136190
Accreditation; continuing medical education; continuing medical education credit; funding; sponsorship
5.  MedReach: building an Area Health Education Center medical information outreach system for Northwest Ohio*† 
In collaboration with regional partners in northwest Ohio, the Area Health Education Center (AHEC) program at the Medical College of Ohio (MCO) at Toledo is reaching out to underserved areas, helping to provide educational opportunities to health care professionals in these communities. This paper describes the development of MedReach, a medical information outreach system that connects regional AHEC sites to MCO via the Internet. MedReach provides physicians and other health care professionals access and support to search computerized textbooks and databases for current information on medical diagnoses, treatments, and research. A unique aspect of the MedReach project is that users are able to receive personal help with information retrieval by calling or emailing MCO's outreach librarian. Periodically, the AHEC program and the Mulford Library at MCO also sponsor an educational program, titled “Medical Applications of Computers,” for regional practitioners. Current feedback on both the medical information outreach system and the educational program has been positive.
PMCID: PMC116405  PMID: 12113517
6.  Stakeholder perspectives on implementing the National Cancer Institute’s patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) 
The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminology Criteria for Adverse Events, called the “PRO-CTCAE.” The PRO-CTCAE consists of a library of patient-reported items which can be administered in clinical trials to directly capture the patient experience of adverse events during cancer treatment, as well as a software platform for administering these items via computer or telephone. In order to better understand the impressions of stakeholders involved in cancer clinical research about the potential value of the PRO-CTCAE approach to capturing adverse event information in clinical research, as well as their perspectives about barriers and strategies for implementing the PRO-CTCAE in NCI-sponsored cancer trials, a survey was conducted. A survey including structured and open-ended questions was developed to elicit perceptions about the use of patient-reported outcomes (PROs) for adverse event reporting, and to explore logistical considerations for implementing the PRO-CTCAE in cancer trials. The survey was distributed electronically and by paper to a convenience sample of leadership and committee members in the NCI’s cooperative group network, including principal investigators, clinical investigators, research nurses, data managers, patient advocates, and representatives of the NCI and Food and Drug Administration. Between October, 2008 through February, 2009, 727 surveys were collected. Most respondents (93%) agreed that patient reporting of adverse symptoms would be useful for improving understanding of the patient experience with treatment in cancer trials, and 88%, 80%, and 76%, respectively, endorsed that administration of PRO-CTCAE items in clinical trials would improve the completeness, accuracy, and efficiency of symptom data collection. More than three fourths believed that patient reports would be useful for informing treatment dose modifications and towards FDA regulatory evaluation of drugs. Eighty-eight percent felt that patients in clinical trials would be willing to self-report adverse symptoms at clinic visits via computer, and 68% felt patients would self-report weekly from home via the internet or an automated telephone system. Lack of computers and limited space and personnel were seen as potential barriers to in-clinic self-reporting, but these were judged to be surmountable with adequate funding. The PRO-CTCAE items and software are viewed by a majority of survey respondents as a means to improve adverse event data quality and comprehensiveness, enhance clinical decision-making, and foster patient-clinician communication. Research is ongoing to assess the measurement properties and feasibility of implementing this measure in cancer clinical trials.
doi:10.1007/s13142-011-0025-3
PMCID: PMC3717706  PMID: 24073038
Patient-reported outcomes; Symptoms, adverse events; Oncology; Cancer, Clinical trials; Toxicity, safety; Tolerability; Comparative effectiveness research; Cooperative groups; National Cancer Institute
7.  The Recurring Bibliographies Program of MEDLARS * 
Recurring bibliographies are by-products of the MEDLARS system which are prepared by the National Library of Medicine in collaboration with nonprofit scientific and professional societies and institutions and government agencies that represent a specialty area of biomedical research or practice. The sponsor generally assumes responsibility for the costs of publication and distribution. At present MEDLARS has a planned capacity of fifty such recurring bibliographies. The subject parameters and format are defined by the representatives of the sponsoring organization and the NLM Search, MeSH, and Index staffs. As citations are regularly put into the MEDLARS store, each one that qualifies for a recurring bibliography is identified and tagged by the computer with the number assigned to the pertinent RB. The MEDLARS store is searched for citations for a particular recurring bibliography according to the schedule specified by the sponsoring organization, and the output is printed from a GRACE tape.
PMCID: PMC198401  PMID: 5325816
8.  Publicly Funded Clinical Trials and the Future of Cancer Care 
The Oncologist  2013;18(2):232-238.
Publicly sponsored trials, conducted primarily by cooperative groups sponsored by the National Cancer Institute, seek to optimize therapy for a particular disease, create new knowledge, and improve public health; these trials can also result in label extension of a drug and even in initial drug approval. This lecture examines the contributions to cancer care of the cooperative groups, the ongoing reorganization of the cooperative groups to form a national clinical trials network, as well as opportunities for developing and refining new cancer treatments and disseminating results to the medical community and the general public.
Publicly sponsored trials, conducted primarily by cooperative groups sponsored by the National Cancer Institute, and commercially sponsored trials are necessary to create new knowledge, improve the care of oncology patients, and develop new drugs and devices. Commercial sponsors launch clinical trials that will result in drug approval, label extension, expansion of market share, and an increase in shareholder value. Conversely, publicly sponsored trials seek to optimize therapy for a particular disease, create new knowledge, and improve public health; these trials can also result in label extension of a drug and even in initial drug approval. Publicly sponsored trials may combine and/or compare drugs developed by different commercial sponsors, develop multimodality therapies (e.g., the combination of chemotherapy and radiation), or develop novel treatment schedules or routes of drug administration (e.g., intraperitoneal chemotherapy). Publicly sponsored trials are more likely to focus on therapies for rare diseases and to study survivorship and quality of life; these areas may not be a priority for commercial entities. Screening and prevention strategies have been developed almost exclusively by the public sector given the large sample size and long follow-up period needed to complete the trial and, therefore, the lack of short-term commercial gain. Finally, given the public nature of the funding, clinical investigators are expected to publish their results even if the outcomes are unfavorable for the investigational therapy. With the ongoing reorganization of the cooperative groups to form a national clinical trials network, opportunities exist to create a robust platform for biomarker discovery and validation through the expanded collection of well-annotated biospecimens obtained from clinical trial participants. Thus, publicly funded trials are vital to developing and refining new cancer treatments and disseminating results to the medical community and the general public.
doi:10.1634/theoncologist.2012-0423
PMCID: PMC3579608  PMID: 23363807
9.  Electronic imaging of the human body. 
The Human Engineering Division of the Armstrong Laboratory (USAF); the Mallinckrodt Institute of Radiology; the Washington University School of Medicine; and the Lister-Hill National Center for Biomedical Communication, National Library of Medicine are sponsoring a working group on electronic imaging of the human body. Electronic imaging of the surface of the human body has been pursued and developed by a number of disciplines including radiology, forensics, surgery, engineering, medical education, and anthropometry. The applications range from reconstructive surgery to computer-aided design (CAD) of protective equipment. Although these areas appear unrelated, they have a great deal of commonality. All the organizations working in this area are faced with the challenges of collecting, reducing, and formatting the data in an efficient and standard manner; storing this data in a computerized database to make it readily accessible; and developing software applications that can visualize, manipulate, and analyze the data. This working group is being established to encourage effective use of the resources of all the various groups and disciplines involved in electronic imaging of the human body surface by providing a forum for discussing progress and challenges with these types of data.
PMCID: PMC2248098  PMID: 1482896
10.  Examining the Use of an Open Digital Health Library for Professionals 
JMIR Research Protocols  2014;3(4):e66.
Background
The Norwegian Electronic Health Library (The Library) is a website for health personnel. Most of the content is also open to the public. Usage statistics have risen sharply in the years 2010-2013.
Objective
We wanted to find out whether the rise was caused by health personnel, the general public, or other factors.
Methods
Since we lacked direct information, we had to use proxy data to shed light on our questions. We applied mixed methods (database of registered users, user survey, usage statistics, and statistics from suppliers), and triangulated between them.
Results
Health personnel were our largest user group, but The Library was also accessed by students, patients, and other groups. Content in Norwegian was preferred to English language content. Concise, practical information was preferred to more comprehensive information. Patient leaflets were the most popular information type. Mobile phone visits differed from personal computer visits both in terms of time of day and what kind of information was viewed.
Conclusions
The Library was used mostly by health personnel, as intended, but our data are inconclusive regarding a possible change in user groups. There was a large degree of consistency in results when using different investigation methods. The survey points toward health personnel being the largest user group, and the usage statistics show that patient leaflets are the most popular content, being viewed by both health personnel and patients.
doi:10.2196/resprot.3820
PMCID: PMC4260083  PMID: 25406825
libraries, medical; access to information; information dissemination; search engine /statistics; Web log analysis
11.  ParallABEL: an R library for generalized parallelization of genome-wide association studies 
BMC Bioinformatics  2010;11:217.
Background
Genome-Wide Association (GWA) analysis is a powerful method for identifying loci associated with complex traits and drug response. Parts of GWA analyses, especially those involving thousands of individuals and consuming hours to months, will benefit from parallel computation. It is arduous acquiring the necessary programming skills to correctly partition and distribute data, control and monitor tasks on clustered computers, and merge output files.
Results
Most components of GWA analysis can be divided into four groups based on the types of input data and statistical outputs. The first group contains statistics computed for a particular Single Nucleotide Polymorphism (SNP), or trait, such as SNP characterization statistics or association test statistics. The input data of this group includes the SNPs/traits. The second group concerns statistics characterizing an individual in a study, for example, the summary statistics of genotype quality for each sample. The input data of this group includes individuals. The third group consists of pair-wise statistics derived from analyses between each pair of individuals in the study, for example genome-wide identity-by-state or genomic kinship analyses. The input data of this group includes pairs of SNPs/traits. The final group concerns pair-wise statistics derived for pairs of SNPs, such as the linkage disequilibrium characterisation. The input data of this group includes pairs of individuals. We developed the ParallABEL library, which utilizes the Rmpi library, to parallelize these four types of computations. ParallABEL library is not only aimed at GenABEL, but may also be employed to parallelize various GWA packages in R. The data set from the North American Rheumatoid Arthritis Consortium (NARAC) includes 2,062 individuals with 545,080, SNPs' genotyping, was used to measure ParallABEL performance. Almost perfect speed-up was achieved for many types of analyses. For example, the computing time for the identity-by-state matrix was linearly reduced from approximately eight hours to one hour when ParallABEL employed eight processors.
Conclusions
Executing genome-wide association analysis using the ParallABEL library on a computer cluster is an effective way to boost performance, and simplify the parallelization of GWA studies. ParallABEL is a user-friendly parallelization of GenABEL.
doi:10.1186/1471-2105-11-217
PMCID: PMC2879286  PMID: 20429914
12.  Friends of the library groups in health sciences libraries. 
The Houston Academy of Medicine--Texas Medical Center (HAM--TMC) Library collected data on friends of the library groups from 103 health sciences libraries, using a mail questionnaire. Sixteen of the responding libraries had independent friends groups; seven had friends groups that were subordinate to a university group. The sixteen independent groups gave as their major purposes (1) to raise money for their associated library and (2) to develop support for their library. These groups contributed an average of $4,870 a year to their libraries, the money being used primarily to purchase rare books and working-collection books and to sponsor social events. The subordinate groups contributed relatively little money to the health sciences libraries responding to the survey.
PMCID: PMC199489  PMID: 678699
13.  Frequency-modulated electromagnetic neural stimulation (FREMS) as a treatment for symptomatic diabetic neuropathy: results from a double-blind, randomised, multicentre, long-term, placebo-controlled clinical trial 
Diabetologia  2012;56(3):467-475.
Aims/hypothesis
The aim was to evaluate the efficacy and safety of transcutaneous frequency-modulated electromagnetic neural stimulation (frequency rhythmic electrical modulation system, FREMS) as a treatment for symptomatic peripheral neuropathy in patients with diabetes mellitus.
Methods
This was a double-blind, randomised, multicentre, parallel-group study of three series, each of ten treatment sessions of FREMS or placebo administered within 3 weeks, 3 months apart, with an overall follow-up of about 51 weeks. The primary endpoint was the change in nerve conduction velocity (NCV) of deep peroneal, tibial and sural nerves. Secondary endpoints included the effects of treatment on pain, tactile, thermal and vibration sensations. Patients eligible to participate were aged 18–75 years with diabetes for ≥1 year, HbA1c <11.0% (97 mmol/mol), with symptomatic diabetic polyneuropathy at the lower extremities (i.e. abnormal amplitude, latency or NCV of either tibial, deep peroneal or sural nerve, but with an evocable potential and measurable NCV of the sural nerve), a Michigan Diabetes Neuropathy Score ≥7 and on a stable dose of medications for diabetic neuropathy in the month prior to enrolment. Data were collected in an outpatient setting. Participants were allocated to the FREMS or placebo arm (1:1 ratio) according to a sequence generated by a computer random number generator, without block or stratification factors. Investigators digitised patients’ date of birth and site number into an interactive voice recording system to obtain the assigned treatment. Participants, investigators conducting the trial, or people assessing the outcomes were blinded to group assignment.
Results
Patients (n = 110) with symptomatic neuropathy were randomised to FREMS (n = 54) or placebo (n = 56). In the intention-to-treat population (50 FREMS, 51 placebo), changes in NCV of the three examined nerves were not different between FREMS and placebo (deep peroneal [means ± SE]: 0.74 ± 0.71 vs 0.06 ± 1.38 m/s; tibial: 2.08 ± 0.84 vs 0.61 ± 0.43 m/s; and sural: 0.80 ± 1.08 vs −0.91 ± 1.13 m/s; FREMS vs placebo, respectively). FREMS induced a significant reduction in day and night pain as measured by a visual analogue scale immediately after each treatment session, although this beneficial effect was no longer measurable 3 months after treatment. Compared with the placebo group, in the FREMS group the cold sensation threshold was significantly improved, while non-significant differences were observed in the vibration and warm sensation thresholds. No relevant side effects were recorded during the study.
Conclusions/interpretation
FREMS proved to be a safe treatment for symptomatic diabetic neuropathy, with immediate, although transient, reduction in pain, and no effect on NCV.
Trial registration
ClinicalTrials.gov NCT01628627
Funding
The clinical trial was sponsored by Lorenz Biotech (Medolla, Italy), lately Lorenz Lifetech (Ozzano dell’Emilia, Italy).
Electronic supplementary material
The online version of this article (doi:10.1007/s00125-012-2795-7) contains peer-reviewed but unedited supplementary material, which is available to authorised users.
doi:10.1007/s00125-012-2795-7
PMCID: PMC3563945  PMID: 23238789
Diabetic neuropathy; Electrical stimulation; Nerve conduction studies; Neuropathic pain; Neurostimulation therapy; Randomised clinical trial
14.  Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial 
Diabetologia  2013;56(12):2582-2592.
Aims/hypothesis
The aim of this work was to evaluate the efficacy and safety of canagliflozin vs placebo and sitagliptin in patients with type 2 diabetes who were being treated with background metformin.
Methods
This randomised, double-blind, four-arm, parallel-group, Phase 3 study was conducted at 169 centres in 22 countries between April 2010 and August 2012. Participants (N = 1,284) with type 2 diabetes aged ≥18 and ≤80 years who had inadequate glycaemic control (HbA1c ≥7.0% [53 mmol/mol] and ≤10.5% [91 mmol/mol]) on metformin therapy received canagliflozin 100 mg or 300 mg, sitagliptin 100 mg, or placebo (n = 368, 367, 366, 183, respectively) for a 26 week, placebo- and active-controlled period followed by a 26 week, active-controlled period (placebo group switched to sitagliptin [placebo/sitagliptin]) and were included in the modified intent-to-treat analysis set. Randomisation was performed using a computer-generated schedule; participants, study centres and the sponsor were blinded to group assignment. The primary endpoint was change from baseline in HbA1c at week 26; secondary endpoints included changes in HbA1c (week 52) and fasting plasma glucose (FPG), body weight, and systolic blood pressure (BP; weeks 26 and 52). Adverse events (AEs) were recorded throughout the study.
Results
At week 26, canagliflozin 100 mg and 300 mg reduced HbA1c vs placebo (−0.79%, –0.94%, –0.17%, respectively; p < 0.001). At week 52, canagliflozin 100 mg and 300 mg demonstrated non-inferiority, and canagliflozin 300 mg demonstrated statistical superiority, to sitagliptin in lowering HbA1c (−0.73%, –0.88%,–0.73%, respectively); differences (95% CI) vs sitagliptin were 0% (−0.12, 0.12) and −0.15% (−0.27, –0.03), respectively. Canagliflozin 100 mg and 300 mg reduced body weight vs placebo (week 26: –3.7%, –4.2%, –1.2%, respectively; p < 0.001) and sitagliptin (week 52: –3.8%, –4.2%, –1.3%, respectively; p < 0.001). Both canagliflozin doses reduced FPG and systolic BP vs placebo (week 26) and sitagliptin (week 52) (p < 0.001). Overall AE and AE-related discontinuation rates were generally similar across groups, but higher with canagliflozin 100 mg. Genital mycotic infection and osmotic diuresis-related AE rates were higher with canagliflozin; few led to discontinuations. Hypoglycaemia incidence was higher with canagliflozin.
Conclusions/interpretation
Canagliflozin improved glycaemia and reduced body weight vs placebo (week 26) and sitagliptin (week 52) and was generally well tolerated in patients with type 2 diabetes on metformin.
Clinical trial registry
ClinicalTrials.gov NCT01106677
Funding
This study was supported by Janssen Research & Development, LLC.
Electronic supplementary material
The online version of this article (doi:10.1007/s00125-013-3039-1) contains peer-reviewed but unedited supplementary material, which is available to authorised users.
doi:10.1007/s00125-013-3039-1
PMCID: PMC3825495  PMID: 24026211
Canagliflozin; Metformin; Sitagliptin; Sodium glucose co-transporter 2 (SGLT2) inhibitor; Type 2 diabetes mellitus
15.  Health Science Libraries of National, State, and Local Medical Organizations 
This second survey of medical society-sponsored libraries has been expanded to include national association libraries in allied medical fields, as well as special libraries which do not fall into categories established for the MLA survey of health science libraries. A total of fifty-eight libraries in this subset have been identified, and selected characteristics have been measured. Observations are made concerning methodology, user population, and services.
PMCID: PMC199050  PMID: 6041830
16.  A MEDLINE feasibility study. 
A MEDLINE feasibility study was conducted with the Northeastern Consortium for Health Information (NECHI) and sponsored by the New England Regional Medical Library Service. It is based on the theory that most potential users and supporters of MEDLINE within hospitals are unaware of its usefulness and applications, and that there exists a need for expanding MEDLINE services to more hospital libraries. The purpose of the study was to provide NECHI with an evaluation of MEDLINE as a feasible service by ascertaining the need and by evaluating the usefulness, satisfaction, and costs of the system. The study demonstrated sufficient use of MEDLINE to justify implementation within NECHI and it provided useful data to determine the future of MEDLINE in each institution. It documented that utilization improved rapidly with publicity and the presence of the system within an institution, that MEDLINE can be an effective and economical complement to the traditional reference services used to support information needs in hospitals, and that more hospital libraries should be able to implement MEDLINE to their advantage once potential users and supporters have been exposed to the system.
PMCID: PMC226508  PMID: 6998531
17.  Educational services in health sciences libraries: a content analysis of the literature, 1987-1994. 
The recent literature (1987-1994) describing educational services of health sciences librarians was analyzed for content. Variables examined included publication journal, country, type of article (description, review, or advocacy), target audience of education services, and subject of article. Articles that reported research results also were identified. Of 123 articles studied, 82.1% were descriptive, 14.6% advocacy, and 3.3% reviews. Library users were the primary target audience (85.1%), an increase over the percentage reported in an earlier study of the 1975-1986 literature. Librarians were the target audience in 12.8% of the articles, a decrease from the previous study's findings. There was an increase in educational offerings by academic libraries, which sponsored 83.2% of programs, while hospital libraries' sponsorship decreased to 5% of programs reported in the literature. The analysis identified a major need for research related to educational activities in health sciences libraries.
PMCID: PMC226057  PMID: 8547899
18.  Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis 
PLoS Medicine  2009;6(9):e1000144.
Joseph Ross and colleagues examine publication rates of clinical trials and find low rates of publication even following registration in Clinicaltrials.gov.
Background
ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.
Methods and Findings
We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515), nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46%) of trials were published, among which 96 (31%) provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357) were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001), but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22). Among trials that reported an end date, 75 of 123 (61%) completed prior to 2004, 50 of 96 (52%) completed during 2004, and 62 of 149 (42%) completed during 2005 were published (p = 0.006).
Conclusions
Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data elements, the potential for ClinicalTrials.gov to address selective publication of clinical trials will be limited.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
People assume that whenever they are ill, health care professionals will make sure they get the best available treatment. But how do clinicians know which treatment is most appropriate? In the past, clinicians used their own experience to make treatment decisions. Nowadays, they rely on evidence-based medicine—the systematic review and appraisal of the results of clinical trials, studies that investigate the efficacy and safety of medical interventions in people. However, evidence-based medicine can only be effective if all the results from clinical trials are published promptly in medical journals. Unfortunately, the results of trials in which a new drug did not perform better than existing drugs or in which it had unwanted side effects often remain unpublished or only appear in the public domain many years after the drug has been approved for clinical use by the US Food and Drug Administration (FDA) and other governmental bodies.
Why Was This Study Done?
The extent of this “selective” publication, which can impair evidence-based clinical practice, remains unclear but is thought to be substantial. In this study, the researchers investigate the problem of selective publication by systematically examining the extent of publication of the results of trials registered in ClinicalTrials.gov, a Web-based registry of US and international clinical trials. ClinicalTrials.gov was established in 2000 by the US National Library of Medicine in response to the 1997 FDA Modernization Act. This act required preregistration of all trials of new drugs to provide the public with information about trials in which they might be able to participate. Mandatory data elements for registration in ClinicalTrials.gov initially included the trial's title, the condition studied in the trial, the trial design, and the intervention studied. In September 2007, the FDA Amendments Act expanded the mandatory requirements for registration in ClinicalTrials.gov by making it necessary, for example, to report the trial start date and to report primary and secondary outcomes (the effect of the intervention on predefined clinical measurements) in the registry within 2 years of trial completion.
What Did the Researchers Do and Find?
The researchers identified 7,515 trials that were registered within ClinicalTrials.gov after December 31, 1999 (excluding phase I, safety trials), and whose record indicated trial completion by June 8, 2007. Most of these trials reported all the mandatory data elements that were required by ClinicalTrials.gov before the FDA Amendments Act but reporting of optional data elements was less complete. For example, only two-thirds of the trials reported their primary outcome. Next, the researchers randomly selected 10% of the trials and, after excluding trials whose completion date was after December 31, 2005 (to allow at least two years for publication), determined the publication status of this subsample by systematically searching MEDLINE (an online database of articles published in selected medical and scientific journals). Fewer than half of the trials in the subsample had been published, and the citation for only a third of these publications had been entered into ClinicalTrials.gov. Only 40% of industry-sponsored trials had been published compared to 56% of nonindustry/nongovernment-sponsored trials, a difference that is unlikely to have occurred by chance. Finally, 61% of trials with a completion date before 2004 had been published, but only 42% of trials completed during 2005 had been published.
What Do These Findings Mean?
These findings indicate that, over the period studied, critical trial information was not included in the ClinicalTrials.gov registry. The FDA Amendments Act should remedy some of these shortcomings but only if the accuracy and completeness of the information in ClinicalTrials.gov is carefully monitored. These findings also reveal that registration in ClinicalTrials.gov does not guarantee that trial results will appear in a timely manner in the scientific literature. However, they do not address the reasons for selective publication (which may be, in part, because it is harder to publish negative results than positive results), and they are potentially limited by the methods used to discover whether trial results had been published. Nevertheless, these findings suggest that the FDA, trial sponsors, and the scientific community all need to make a firm commitment to minimize the selective publication of trial results to ensure that patients and clinicians have access to the information they need to make fully informed treatment decisions.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000144.
PLoS Medicine recently published two related articles on selected publication by Ida Sim and colleagues and by Lisa Bero and colleagues and an editorial discussing the FDA Amendments Act
ClinicalTrials.gov provides information about the US National Institutes of Health clinical trial registry, including background information about clinical trials, and a fact sheet detailing the requirements of the FDA Amendments Act 2007 for trial registration
The US Food and Drug Administration provides further information about drug approval in the US for consumers and health care professionals
doi:10.1371/journal.pmed.1000144
PMCID: PMC2728480  PMID: 19901971
19.  Vermont Cancer Center DNA Analysis Facility 
Journal of Biomolecular Techniques : JBT  2010;21(3 Suppl):S76-S77.
CF-32
The Vermont Cancer Center DNA Analysis Facility provides an array of fast, affordable, user-friendly DNA analysis services to the members of the Vermont Cancer Center and the University of Vermont research community and region. Primary services offered for a fee include DNA sequencing, real-time quantitative PCR, DNA fragment analysis (microsatellite instability, haplotyping, AFLP, and T-RFLP), SNP detection, nucleic acid extraction, image analysis (phosphorimaging, fluorescent detection, DNA and protein stain imaging, chemiluminescence, chemifluorescence) and densitometry), and protein gel spot excision with a BioRad EXQuest Spot Cutter. The facility provides a variety of other important benefits free of charge to our users. These include access to two NanoDrop Spectrophotometers, two MJ Research Gradient Cyclers, and sponsoring seminars on new technologies, holding tutorials on software and user driven instrumentation, primer and probe design, obtaining discounted pricing on common reagents, and providing data analysis, troubleshooting and consultation in experimental design. Our annual Open House is a popular day long event highlighting all of our services. In January 2007, the facility began a new User Educational Seminar Series with the goal to meet with users on a monthly basis to educate and promote services currently being provided in the facility. A computer workstation area is adjacent to the main lab and has freeware and purchased programs available for data analysis and review with full support from nearby facility staff. The facility uses a bioinformatic platform known as the UVM BioDesktop to facilitate the workflow for both the users and the staff of the facility. Users of the facility create a password protected BioDesktop account for online ordering of all services, viewing and archiving data, and accessing data analysis tools. The facility staff uses their BioDesktop account for uploading completed data, creating sample sheets for the instruments, exporting billing information, and tracking completion of orders.
PMCID: PMC2918011
20.  The tissue microarray data exchange specification: A community-based, open source tool for sharing tissue microarray data 
Background
Tissue Microarrays (TMAs) allow researchers to examine hundreds of small tissue samples on a single glass slide. The information held in a single TMA slide may easily involve Gigabytes of data. To benefit from TMA technology, the scientific community needs an open source TMA data exchange specification that will convey all of the data in a TMA experiment in a format that is understandable to both humans and computers. A data exchange specification for TMAs allows researchers to submit their data to journals and to public data repositories and to share or merge data from different laboratories. In May 2001, the Association of Pathology Informatics (API) hosted the first in a series of four workshops, co-sponsored by the National Cancer Institute, to develop an open, community-supported TMA data exchange specification.
Methods
A draft tissue microarray data exchange specification was developed through workshop meetings. The first workshop confirmed community support for the effort and urged the creation of an open XML-based specification. This was to evolve in steps with approval for each step coming from the stakeholders in the user community during open workshops. By the fourth workshop, held October, 2002, a set of Common Data Elements (CDEs) was established as well as a basic strategy for organizing TMA data in self-describing XML documents.
Results
The TMA data exchange specification is a well-formed XML document with four required sections: 1) Header, containing the specification Dublin Core identifiers, 2) Block, describing the paraffin-embedded array of tissues, 3)Slide, describing the glass slides produced from the Block, and 4) Core, containing all data related to the individual tissue samples contained in the array. Eighty CDEs, conforming to the ISO-11179 specification for data elements constitute XML tags used in the TMA data exchange specification. A set of six simple semantic rules describe the complete data exchange specification. Anyone using the data exchange specification can validate their TMA files using a software implementation written in Perl and distributed as a supplemental file with this publication.
Conclusion
The TMA data exchange specification is now available in a draft form with community-approved Common Data Elements and a community-approved general file format and data structure. The specification can be freely used by the scientific community. Efforts sponsored by the Association for Pathology Informatics to refine the draft TMA data exchange specification are expected to continue for at least two more years. The interested public is invited to participate in these open efforts. Information on future workshops will be posted at (API we site).
doi:10.1186/1472-6947-3-5
PMCID: PMC165444  PMID: 12769826
21.  HPCC and the National Information Infrastructure: an overview. 
The National Information Infrastructure (NII) or "information superhighway" is a high-priority federal initiative to combine communications networks, computers, databases, and consumer electronics to deliver information services to all U.S. citizens. The NII will be used to improve government and social services while cutting administrative costs. Operated by the private sector, the NII will rely on advanced technologies developed under the direction of the federal High Performance Computing and Communications (HPCC) Program. These include computing systems capable of performing trillions of operations (teraops) per second and networks capable of transmitting billions of bits (gigabits) per second. Among other activities, the HPCC Program supports the national supercomputer research centers, the federal portion of the Internet, and the development of interface software, such as Mosaic, that facilitates access to network information services. Health care has been identified as a critical demonstration area for HPCC technology and an important application area for the NII. As an HPCC participant, the National Library of Medicine (NLM) assists hospitals and medical centers to connect to the Internet through projects directed by the Regional Medical Libraries and through an Internet Connections Program cosponsored by the National Science Foundation. In addition to using the Internet to provide enhanced access to its own information services, NLM sponsors health-related applications of HPCC technology. Examples include the "Visible Human" project and recently awarded contracts for test-bed networks to share patient data and medical images, telemedicine projects to provide consultation and medical care to patients in rural areas, and advanced computer simulations of human anatomy for training in "virtual surgery."
PMCID: PMC225993  PMID: 7703935
22.  Interactions between physicians and the pharmaceutical industry: what does the literature say? 
OBJECTIVE: To determine the effect of three types of interaction between physicians and the pharmaceutical industry--company-funded clinical trials, company-sponsored continuing medical education (CME) and information for physicians supplied by pharmaceutical detailers--on orientation and quality of clinical trials, content of CME courses and physicians' prescribing behaviour. DATA SOURCES: MEDLINE and HEALTH searches for English-language articles published from 1978 to 1993, supplemented by material from the author's personal collection. STUDY SELECTION: A total of 227 papers from the MEDLINE and HEALTH searches and about 2000 items from the author's library were initially reviewed. The following selection criteria were used: studies conducted in Australia, Canada, New Zealand, Britain and the United States; studies conducted after 1977; quantitative surveys containing details of the survey methods; studies on the orientation and quality of company-funded clinical trials and on the content of CME courses giving explicit criteria used in the evaluation; and reports on the outcome of interactions stating how the outcomes were assessed. Thirty-six studies met these criteria. DATA EXTRACTION: Information was extracted on five topics: physicians' attitudes toward drug industry interactions, frequency with which physicians participate in the interactions, orientation and quality of company-funded clinical trials, content of company-sponsored CME courses and changes in physicians' prescribing behaviour as a result of an interaction. DATA SYNTHESIS: Although most physicians participate only occasionally in company-sponsored clinical trials, most see detailers and attend company-sponsored CME courses. However, physicians do not have a very high opinion of the information from detailers or of company-sponsored CME events. Many doctors regard pharmaceutical companies as an important source of funding for clinical trials, but they also have concerns about accepting money from this source. Company funding of clinical trials may affect the quality of the trials and the types of research that physicians undertake. Company-sponsored CME courses may have a commercial bias even if conducted under guidelines designed to ensure the independence of the event. All three types of interactions affect physicians' prescribing behaviour and, in the case of obtaining information from detailers, physicians' prescribing practices are less appropriate as a result of the interaction. CONCLUSIONS: Physicians are affected by their interactions with the pharmaceutical industry. Further research needs to be done in most cases to determine whether such interactions lead to more or less appropriate prescribing practices. The CMA's guidelines on this topic should be evaluated to see whether they are effective in controlling physician-industry interactions. Further measures may be necessary if the guidelines fail to prevent negative effects on prescribing practices.
PMCID: PMC1485922  PMID: 8221424
23.  Transitioning to the Internet: results of a National Library of Medicine user survey. 
In late 1995, several months prior to the introduction of Internet Grateful Med, the National Library of Medicine (NLM) conducted a customer survey as part of its efforts to make a transition from Grateful Med to new forms of electronic information access and retrieval. A questionnaire survey was mailed to a sample of 2,500 online users randomly selected from domestic users (excluding fixed-fee users) who searched NLM databases during the second quarter of 1995. The final response rate was nearly 83% of eligible respondents. About 70% of NLM customers responding already had access to the Internet, and of those, more than 90% had access to the World Wide Web. However, only 26% of customers with Internet access were using the Internet to access NLM databases. Health care providers account for about 46% of NLM customers but, as a group, search NLM databases relatively infrequently even though they have higher-end equipment. Librarians and information professionals represent about one-fifth of NLM customers and are by far the most intensive users, but tend to have lower-end equipment. Overall, the survey results provide a strong basis for the transition to Internet-based delivery of NLM online database services, including Internet Grateful Med and the NLM family of World Wide Web sites. However, Internet access is uneven, especially in rural areas and at hospitals. This reinforces the need for continuing special outreach efforts directed at improving access for rural and hospital-based users and rural libraries, upgrading computer equipment for medical librarians, and training health care providers in more effective use of Internet-based biomedical information resources.
PMCID: PMC226289  PMID: 9431421
24.  Relationship between Funding Source and Conclusion among Nutrition-Related Scientific Articles 
PLoS Medicine  2007;4(1):e5.
Background
Industrial support of biomedical research may bias scientific conclusions, as demonstrated by recent analyses of pharmaceutical studies. However, this issue has not been systematically examined in the area of nutrition research. The purpose of this study is to characterize financial sponsorship of scientific articles addressing the health effects of three commonly consumed beverages, and to determine how sponsorship affects published conclusions.
Methods and Findings
Medline searches of worldwide literature were used to identify three article types (interventional studies, observational studies, and scientific reviews) about soft drinks, juice, and milk published between 1 January, 1999 and 31 December, 2003. Financial sponsorship and article conclusions were classified by independent groups of coinvestigators. The relationship between sponsorship and conclusions was explored by exact tests and regression analyses, controlling for covariates. 206 articles were included in the study, of which 111 declared financial sponsorship. Of these, 22% had all industry funding, 47% had no industry funding, and 32% had mixed funding. Funding source was significantly related to conclusions when considering all article types (p = 0.037). For interventional studies, the proportion with unfavorable conclusions was 0% for all industry funding versus 37% for no industry funding (p = 0.009). The odds ratio of a favorable versus unfavorable conclusion was 7.61 (95% confidence interval 1.27 to 45.73), comparing articles with all industry funding to no industry funding.
Conclusions
Industry funding of nutrition-related scientific articles may bias conclusions in favor of sponsors' products, with potentially significant implications for public health.
In 111 scientific articles on nonalcoholic beverages, articles with all industry funding were more than 7 times more likely to have favorable conclusions compared with articles with no industry funding.
Editors' Summary
Background.
Much of the money available for doing medical research comes from companies, as opposed to government agencies or charities. There is some evidence that when a research study is sponsored by an organization that has a financial interest in the outcome, the study is more likely to produce results that favor the funder (this is called “sponsorship bias”). This phenomenon is worrying, because if our knowledge about effectiveness and safety of medicines is based on biased findings, patients could suffer. However, it is not clear whether sponsorship bias extends beyond research into drugs, but also affects other types of research that is in the public interest. For example, research into the health benefits, or otherwise, of different types of food and drink may affect government guidelines, regulations, and the behavior patterns of members of the public. Were sponsorship bias also to exist in this area of research, the health of the wider public could be affected.
Why Was This Study Done?
There is not a great deal of evidence about whether sponsorship bias affects nutritional research (scientific studies that look at the relationship between food and/or drink, and health or disease states). Therefore, the group of researchers here set out to collect information from published nutritional research papers, to see if the type of sponsorship for the research studies was in any way linked with whether the main conclusions were favorable or unfavorable to the sponsor.
What Did the Researchers Do and Find?
The research study reported here used the scientific literature as a source of data. The researchers chose to examine one particular area of nutrition (nonalcoholic drinks including soft drinks, juices, and milk), so that their investigation would not be affected too much by variability between the different types of nutritional research. Using literature searches, the researchers identified all original research and scientific review articles published between January 1999 and December 2003 that examined soft drinks, juices, and milk; described research carried out in humans; and at the same time drew conclusions relevant to health or disease. Then, information from each published article was categorized: the conclusions were coded as either favorable, unfavorable, or neutral in relation to the health effects of the products being studied, and the article's funding was coded as either all industry (ie, food/drinks companies), no industry, or mixed. 206 published articles were analyzed and only 54% declared funding. The researchers found that, overall, there was a strong association between the type of funding available for these articles and the conclusions that were drawn. Articles sponsored exclusively by food/drinks companies were four to eight times more likely to have conclusions favorable to the financial interests of the sponsoring company than articles which were not sponsored by food or drinks companies.
What Do These Findings Mean?
These findings suggest that a high potential for bias exists in research into the health benefits or harms of nonalcoholic drinks. It is not clear from this research study why or how this bias comes about, but there are many different mechanisms that might cause it. The researchers suggest that certain initiatives might help to reduce bias, for example, increasing independent funding of nutrition research.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/doi:10.1371/journal.pmed.0040005.
Conflict of Interest definition from Wikipedia (Wikipedia is an internet encyclopedia that anyone can edit)
The International Committee of Medical Journal Editors provides standard guidelines for practices at medical journals, including a section on sponsorship, authorship, and accountability
The Committee on Publication Ethics is a forum for journal editors to discuss issues related to the integrity of the scientific record, and it provides guidelines for editors and case studies for reference
The Good Publication Practice guidelines outline standards for responsible publication of research sponsored by pharmaceutical companies
doi:10.1371/journal.pmed.0040005
PMCID: PMC1764435  PMID: 17214504
25.  Characteristics of project management at institutions sponsoring National Library of Medicine MedlinePlus Go Local* 
Objectives:
Through interviews with the National Library of Medicine's MedlinePlus Go Local collaborators, an evaluation team sought to identify process characteristics that are critical for long-term sustainability of Go Local projects and to describe the impact that Go Local projects have on sponsoring institutions.
Methods:
Go Local project coordinators (n = 44) at 31 sponsor institutions participated in semi-structured interviews about their experiences developing and maintaining Go Local sites. Interviews were summarized, checked for accuracy by the participating librarians, and analyzed using a general inductive methodology.
Results:
Institutional factors that support Go Local projects were identified through the interviews, as well as strategies for staffing and partnerships with external organizations. Positive outcomes for sponsoring institutions also were identified.
Conclusions:
The findings may influence the National Library of Medicine team's decisions about improvements to its Go Local system and the support it provides to sponsoring institutions. The findings may benefit current sponsoring institutions as well as those considering or planning a Go Local project.
doi:10.3163/1536-5050.98.1.018
PMCID: PMC2801972  PMID: 20098657

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