Tag Archives: Research

Standards and Services and PRISMA, Oh My! Systematic Reviews at MLAnet16, Day One

First posted at the MLAnet16 blog: http://www.mlanet.org/blog/standards-and-services-and-prisma,-oh-my!-systematic-reviews-at-mlanet16,-day-one


Toronto Scenery

Wow, wow, wow! What an AMAZING day! I’m at the Medical Library Association Annual Meeting, and trying to get to as many of the systematic review events as I can. Today is the first full day of the conference, and it was a jackpot — PRISMA for searches, a session on EBM/EBHC training, and a session on systematic review services. Lots of posters, too, but I haven’t had a chance to go look at those yet.

I tweeted a screenshot of the special session on systematic reviews this afternoon.

Dean Giustini asked me what’s new, so let me get right to that.

PRISMA

I saw an event in the program, something about PRISMA standards, so I thought I’d poke my head in. When I poked my head back out later, I could not stop talking about it. The gist of it is that PRISMA, whom most medical librarians and journal editors know of as providing standards and guidelines for how systematic review data should be reported, are branching out. Me, I’ve been watching with excitement the various PRISMA extensions that have been being added recently. Thsee include standards for reporting protocols, meta-analyses, patient data, abstracts, and more. Well, it turns out there is a pretty substantial team working on developing PRISMA guidelines for reporting search strategies. This is pretty exciting for me! And somehow, I had missed it until today. The group today was opening the results from the original team to a broader audience and asking for reactions. They had come up with 123 guidelines, which they narrowed down to 53, and then we broke into four subgroups (search strategy, grey literature, documenting results, database characteristics) brainstorming about how to narrow down even further, into truly actionable points. I tell you, this is a group to watch.

Some of my favorite lines:

“I did this review according to PRISMA standards.” “You can’t. PRISMA is a ‘reporting’ standard, not a ‘doing.'” (Margaret Foster)

“The faculty are asking individual students to do something that is essentially a team sport.” (Ana Patricia Ayala)

“Cochrane says, ‘You will not limit by language.’ PRISMA says, ‘You will report any limits.'” (Margaret Sampson)

Here is just one of the flip boards from the conversation to whet the appetite of the systematic review methods nerds.

Priorities for Systematic Review Search Strategy Reporting

SYSTEMATIC REVIEW SERVICES

Later in the day, there was a complete session devoted to systematic review services in medical libraries. Yes, this is the same one from the tweet earlier in this post. I was dashing in late from the poster session, so I missed the beginning of the presentation on training needs by Catherine Boden and Hellsten. I was disappointed, because they were citing many wonderful articles I wanted to look into later. I’m sure glad the slides are in the online MLA system, because I’ll have to go find them! Being late also means I didn’t get any photos from their talk. The most provocative concept I pulled from their talk was the idea that systematic reviews are actually “a constellation of related methods rather than a single methodology.” So elegantly put, and so true. It’s a helpful way to reframe how we think about what we do, and is supported by the same drive that is motivating the various PRISMA extensions mentioned above.

MLAnet16 Systematic Review Services

Sarah Vistinini presented for her team on scoping reviews, their similarities to and differences from systematic reviews, and the value of being included in the ENTIRE process (which she cleverly described as giving a “better appreciation of all the moving parts.”). Sarah showed some very cool evidence mapping (see pic above), dot prioritization, and more. There were glowing recommendations of the 2005 Arksey and O’Malley article on scoping review methodologies and a wonderful link to all the references: bit.ly/visin-2016.

Kate Krause presented for a team primarily from the Texas Medical Center Library about their efforts to launch a new systematic review service, and the resulting “opportunities” (wink, wink, nudge, nudge, we all know what THAT means). The moderator described their presentation as a “collective therapy session,” which generated considerable amusement among the audience. The most important parts of her talk were, of course, the solutions! They require systematic review requests to come through an online request form, which gives them solid statistics and allows them to manage workflow better. They are using a memorandum of understanding (MOU) with faculty to facilitate a discussion of the duties, timeline, and expectations. They are providing different levels of service, with some interesting requirements for the highest level of service (like, if I understood correctly, mandatory five face-to-face meetings with the project lead). One curious nugget for which they are seeking the citation was heard at a prior MLA meeting — the more face-to-face meetings you have with a systematic review researcher, the more likely they are to actually publish on the project. They have a wonderful-sounding information packet given to new SR researchers, but I didn’t catch everything in it. I did catch bits (Cochrane timeline? list of other review types?) that make me want to know more!

MLAnet16 Systematic Review Services

Lynn Kysh and Robert E. Johnson presented a talk with the awesome title: “Blinded Ambition, misperceptions & misconceptions of systematic reviews.” They discussed some of the challenges to co-authorship and publication being assumed as an automatic good for librarians working on systematic review teams. Lynn described constraints to completing publication, and described times when librarians there removed their name from articles being submitted for publication because of methodological concerns. Very very interesting content. Well, and then there were the forest plot kittenz.

Last but not least, Maylene Kefeng Qiu represented a team that did the bulk of the work for a rapid review in … three weeks. Intense! Much of the challenge centered around timing, expertise available, staffing, workflow, and management coordination. The librarians on this team actually did the critical appraisal of the articles before giving the final dataset to the faculty member writing the review. My favorite line from her talk was, “Stick to your inclusion/exclusion criteria.” Their slide deck had so many wonderful images illustrating parallels and differences between systematic reviews and rapid reviews. I hope it’s ok if I share just one.

MLAnet16 Systematic Review Services

Celebrating Women Inventors at UofM (for #AdaLovelaceDay)

Ada Lovelace Day in Second Life

Why Ada Lovelace Day matters, asks the Guardian today. Usually people celebrate by highlighting famous women scientists. I asked myself, what about right here, right now? What are women scientists and inventors doing at the University of Michigan?

I figured the best way to find out was to go through the UM Tech Transfer database of Available Technologies for licensing. I skimmed the most recently deposited 100 inventions, looking for women. I found inventions in education and healthcare (even new cell lines!). I also found women inventing new batteries and biosensors, researchers working in engineering and code and physics, and even, yes, gamma rays! Some were prolific with MANY inventions listed recently. Most had one or two. They are ALL fabulous. And I am proud to say I know some of them personally. Take a look. See what cool smart women are inventing here. And remember: The sky is the limit!

Elizabeth W. Anderson – Responsible Conduct of Research for K Awardees (RCR4K) | Trainer’s Guide for Responsible Conduct of Research for K Awardees (RCR4K)

Valeria Bertacco – Post-Silicon Bug Diagnosis with Inconsistent Executions

Sarah Hawley – iCanDecide Conjoint Analysis Breast Cancer Treatment Decision Aid (ICanDecide)

Jane E. Huggins – Direct Brain-Computer Interface for Cognitive Assessment

Lori L. Isom – beta1/Contactin Cell Line

Helen C. Kales – WeCareAdvisor (based on her DICE method for dementia management)

Naheed Wali Khan – Multimodal Imaging in Retinal Diseases

Michelle Meade – Mobile Game for Spinal Cord Injury Health and Behavioral Rehabilitation

Sandra I. Merkel – Face, Legs, Activity, Cry, Consolability (FLACC) Observational Tool as a Measure of Pain

Janis Miller – Self-Instructional Voiding/Intake Diary and Individualizing Target Bladder Health Goals through Beverage Management

Mahta Moghaddam –
Method of Including Full-Wave Source Model in Acoustic and Electromagnetic Scattering and Inverse Scattering Formulations
Antenna and Propagation Model for Free-space Measurements and Experimental Inverse Scattering
Method for Large-Domain Microwave Breast Imaging

Sara Pozzi – Combined Scintillator-based Neutron and Gamma-ray Dosimeter

Emily Kaplan Mower Provost – Smartphone app for aphasia therapy

Mary C. Ruffolo PhD – Online evidence-based practice training modules

Melanie S. Sanford –
Organic Anolyte Materials for Flow Batteries
Generation of Ag18F and its use in the synthesis of PET radiotracers

Mary Simoni – Block M Records (University of Michigan Recordings) (Catalog)

Nancy Butler Songer – Evidence-based Learning Method for K-12 Students to Evaluate the Ecological Impacts of Climate Change

Laurie Sutch – Teaching and Technology Collaborative Workshop Registration System

Amy J. Teddy – Online concussion education for parents and coaches

Margaret S. Wooldridge – Cylinder Pressure and Heat Release Analysis Tool for Advanced Combustion Engines

Laboratory Life Online, Part 1 (A HOTW Post)

Second Life: Nanotechnology Island

There has been a lot of science communication (#SciComm) action on Twitter recently centering around what does life look like for real scientists. I have a head start on this because when I was a little tyke, my dad dragged me into the lab with him and told me things like to watch the door of the High Wind Velocity Testing Lab so that the tornado didn’t get out while he was working on his mass spectrometer lithium sample testing. What can I say? I was gullible. So all those fun lifestyle pithy tweets will come in a later post, but for today, here is proof of presence of laboratories on Twitter. For the record, there are a lot more of these in each category, because Twitter’s search limits don’t return complete results for matches to the search criteria. Basically, that means I found a lot of these by browsing, when I should have been able to find them through search. I hope this is a useful resource. Enjoy!

ABOUT LABORATORIES

American Laboratory https://twitter.com/AmericanLab
Lab Design News https://twitter.com/labdesignnews
Lab Guru https://twitter.com/Labguru
Lab Life (@LabLife) https://twitter.com/LabLife
Lab Spaces https://twitter.com/LabSpaces
Lab TV https://twitter.com/LabTVCuriosity
Laboratory EQAS https://twitter.com/LaboratoryEQAS
Laboratory Equipment https://twitter.com/LabEquipment
Laboratory News https://twitter.com/laboratorynews
Laboratory Products https://twitter.com/labproductsnews

MICHIGAN LABS

Cardinale Lab (ecology and biodiversity lab) https://twitter.com/CardinaleLab
Decision Lab https://twitter.com/DecisionLab
Edelstein Lab https://twitter.com/EdelsteinLab
Lauring Lab https://twitter.com/LauringLab
Mahon Lab @CMU_Antarctica https://www.twitter.com/CMU_Antarctica
MiNDLab https://www.twitter.com/MiNDLab_umich
Michigan Tech High Performance Computing (HPC) @MichiganTechHPC https://twitter.com/MichiganTechHPC
MLabs (pathology) https://www.twitter.com/MLabsUM
National Superconducting Cyclotron Laboratory (@NSCL) https://twitter.com/NSCL
NOAA Great Lakes Environmental Research Lab (GLERL) https://twitter.com/NOAA_GLERL
Tronson Lab https://twitter.com/tronsonlab
U.M. Sex Lab https://twitter.com/SexualityLab
U Mich Concept Lab https://twitter.com/UMichConceptLab
University of Michigan Childhood Disparities Research Laboratory (@UMCDRL) https://twitter.com/UMCDRL

U.S. NATIONAL LABS

Ames Laboratory @Ames_Laboratory https://twitter.com/Ames_Laboratory
Argonne National Lab @argonne https://twitter.com/argonne
Berkeley Lab @BerkeleyLab https://twitter.com/berkeleylab
Berkeley Lab CS @LBNLcs https://twitter.com/LBNLcs
Brookhaven Nat’l Lab @BrookhavenLab https://twitter.com/brookhavenlab
DOE Science https://twitter.com/doescience
Energy Sciences Network (ESnet) @ESnetUpdates
Federal Laboratory Consortium for Technology Transfer (FLC) @federallabs
Fermilab @Fermilab
Idaho National Lab @INL https://twitter.com/INL
ISS U.S. National Laboratory, Center for the Advancement of Science in Space (CASIS) (@ISS_CASIS) https://twitter.com/iss_casis
Jefferson Lab P.A. @Jblab
LBNL Media Report @LBNLmediareport
Lawrence Livermore National Laboratory (LLNL) @Livermore_Lab https://twitter.com/Livermore_Lab
Los Alamos National Lab (LANL) @LosAlamosNatLab https://twitter.com/LosAlamosNatLab
Los Alamos National Laboratory (LANL) – Health (@LANL_Health) https://twitter.com/lanl_health
Los Alamos National Laboratory (LANL) – Space https://twitter.com/lanl_space
National Energy Research Scientific Computing Center (NERSC) https://twitter.com/NERSC
National Energy Technology Laboratory (NETL) @NETL_News https://twitter.com/NETL_News
National High Magnetic Field Laboratory @NationalMagLab https://twitter.com/nationalmaglab
National Nuclear Security Administration (NNSA) https://twitter.com/NNSANews
National Renewable Energy Laboratory (NREL) @NREL
NASA Jet Propulsion Laboratory (JPL) @NASAJPL https://twitter.com/NASAJPL
NOAA Atlantic Oceanographic & Meteorological Laboratory (AOML) https://twitter.com/noaa_aoml
NOAA Great Lakes Environmental Research Lab (GLERL) https://twitter.com/NOAA_GLERL
Oak Ridge National Laboratory @ORNL https://twitter.com/ORNL
Oak Ridge National Lab, Manufacturing Demonstration Facility (ORNL Manufacturing) @ORNLMDF https://twitter.com/ORNLMDF
Pacific Northwest National Laboratory (PNNL) @PNNLab https://twitter.com/pnnlab
Princeton Plasma Physics Laboratory (PPPL) @PPPLab
Sandia National Labs @SandiaLabs https://twitter.com/SandiaLabs [Sandia National Labs @SandiaLabsUVM https://twitter.com/SandiaLabsUVM%5D
Sanford Lab @SanfordLab https://twitter.com/SanfordLab
Savannah River National Laboratory @SRSNews https://twitter.com/SRSNews
SLAC National Accelerator Laboratory @SLAClab https://twitter.com/SLAClab
U.S. Army Research Labs https://twitter.com/ArmyResearchLab
U.S. Global Development Lab https://twitter.com/GlobalDevLab

MORE LABS WORTH KNOWING

Arne Lindqvist Lab (cancer research) @LindqvistLab https://twitter.com/LindqvistLab
Boulby Laboratory (deep underground science) https://twitter.com/BoulbyLab
Cavendish Laboratory (physics) https://twitter.com/DeptofPhysics
Happe Lab (autism research) https://twitter.com/HappeLab
Hewlett Packard Labs https://twitter.com/hplabs
HHS Idea Lab https://twitter.com/HHSIDEALab
MIT Lincoln Laboratory https://twitter.com/MITLL
MIT Media Lab https://twitter.com/medialab
National Archives & Records Administration (NARA) Media Labs https://twitter.com/NARAMediaLabs
Public Laboratory (open source) @PublicLab https://twitter.com/PublicLab
Suicidal Behaviour Research Laboratory @SuicideResearch https://twitter.com/suicideresearch
The Food Lab https://twitter.com/TheFoodLab
U.K. National Nuclear Laboratory @UKNNL https://twitter.com/uknnl
Wired Gadget Lab @GadgetLab https://twitter.com/gadgetlab
Wise Laboratory (toxicology) https://twitter.com/WiseLaboratory

From the Arxiv (What Caught My Eye Last Week)

Quantifying the impact of weak, strong, and super ties in scientific careers
Alexander Michael Petersen
PDF: http://arxiv.org/pdf/1509.01804v1.pdf
Soundbite: “We find that super ties contribute to above-average productivity and a 17% citation increase per publication, thus identifying these partnerships – the analog of life partners – as a major factor in science career development.”

Do we need another coffee house? The amenity space and the evolution of neighborhoods
César A. Hidalgo, Elisa E. Castañer
PDF: http://arxiv.org/pdf/1509.02868v1.pdf
Soundbite: “Neighborhoods populated by amenities, such as restaurants, cafes, and libraries, are considered to be a key property of desirable cities. … Finally, we use the Amenity Space to build a recommender system that identifies the amenities that are missing in a neighborhood given its current pattern of specialization.”

Liberating language research from dogmas of the 20th century
Ramon Ferrer-i-Cancho, Carlos Gómez-Rodríguez
PDF: http://arxiv.org/pdf/1509.03295v1.pdf
Soundbite: ” Those tenets can be summarized as a belief in the existence of word order constraints that cannot be explained by evolutionary processes or requirements of performance or learning, and instead require either (a) heavy assumptions that compromise the parsimony of linguistic theory as a whole or (b) explanations based on internal constraints of obscure nature.”
Interesting: “We submitted our commentary to PNAS but it was rejected. We hope that the availability of our submission helps to liberate language research from dogmas of the 20th century”

Estimating Reproducibility in Genome-Wide Association Studies
Wei Jiang, Jing-Hao Xue, Weichuan Yu
PDF: http://arxiv.org/pdf/1508.06715v1.pdf
Soundbite: “This can be used to generate a list of potentially true associations in the irreproducible findings for further scrutiny.”

Nucleosome positioning: resources and tools online
Vladimir B. Teif
PDF: http://arxiv.org/pdf/1508.06916v4.pdf
About: Gene Regulation Info
Includes: Nucleosome positioning datasets sorted by cell type

Combining exome and gene expression datasets in one graphical model of disease to empower the discovery of disease mechanisms
Aziz M. Mezlini, Fabio Fuligni, Adam Shlien, Anna Goldenberg
PDF: http://arxiv.org/pdf/1508.07527v1.pdf
Soundbite: “It is not unusual to observe a significant gene expression change in thousands of genes, the majority being a downstream, rather than the driver, effect (e.g. inflammation, drug response, etc) Additionally, and more importantly, there is a large heterogeneity in gene expression in cancer: many patients within the same subtype will appear to have an abberant expression. These variations are of unknown cause.”

Using Genetic Distance to Infer the Accuracy of Genomic Prediction
Marco Scutari, Ian Mackay, David Balding
PDF: http://arxiv.org/pdf/1509.00415v2.pdf
Soundbite: ” In human genetics, decay curves could be used study to what extent predictions are accurate and thus to improve the performance of medical diagnostics for the general population. In plant and animal breeding, on the other hand, it is common to incorporate distantly related individuals in selection programs to maintain a sufficient level of genetic variability.”

Population genomics of intrapatient HIV-1 evolution
Fabio Zanini, Johanna Brodin, Lina Thebo, Christa Lanz, Göran Bratt, Jan Albert, Richard A. Neher
PDF: http://arxiv.org/pdf/1509.02483v1.pdf
Soundbite: “In most patients, the virus populations was initially homogeneous and diversified over the years, as expected for an infection with a single or small number of similar founder viruses (Keele et al., 2008). In two patients, p3 and p10, the first sample displayed diversity consistent with the transmission of several variants from the same donor.”
Soundbite: “Our reasoning proceeds as follows. Figure 6B indicates that diversity accumulates over a time frame of 2-4 years, i.e., about 1,000 days. Recombination at a rate of 10−5/bp/day hits a genome on average every 100 bps in 1000 days. Mutations further apart than 100bps are hence often separated by recombination and retain little linkage consistent with the observed decay length in Figure 7.”

Inadequate experimental methods and erroneous epilepsy diagnostic criteria result in confounding acquired focal epilepsy with genetic absence epilepsy
Raimondo D’Ambrosio, Clifford L. Eastman, John W. Miller
PDF: http://arxiv.org/pdf/1509.01206v1.pdf
Soundbite: “Because the authors could not induce focal seizures by FPI, they ended up comparing absence epilepsy in their controls with absence epilepsy in FPI rats, and concluded that they look similar. They also used inappropriate epilepsy diagnostic criteria that cannot distinguish between focal non-convulsive seizures and genetic absence epilepsy. Moreover, the authors failed to consider all literature conflicting with their conclusion, and surmised similarities between the absence epilepsy in their rats with the focal seizures we induce by rpFPI.”

Reduction of Alzheimer’s disease beta-amyloid pathology in the absence of gut microbiota
T. Harach, N. Marungruang, N. Dutilleul, V. Cheatham, K. D. Mc Coy, J. J. Neher, M. Jucker, F. Fåk, T., Lasser, T. Bolmont
PDF: http://arxiv.org/pdf/1509.02273v1.pdf
Soundbite: “Our results indicate a microbial involvement in the development of Alzheimer’s disease pathology, and suggest that microbiota may contribute to the development of neurodegenerative diseases.”

Fractal Fluctuations in Human Walking: Comparison of Auditory and Visually Guided Stepping
Philippe Terrier
PDF: http://arxiv.org/pdf/1509.01913v1.pdf
Soundbite: “[B]ecause it can be assumed that AC and VC mobilize the same motor pathways, they can probably be used alternatively in gait rehabilitation. The efficiency of VC to enhance walking abilities in patients with neurological gait disorders needs further studies. However, the high gait variability induced by VC might have detrimental effects, for instance, a lower dynamic balance. This should be taken into account in the development of VC rehabilitation methods.”

The Brain Uses Reliability of Stimulus Information when Making Perceptual Decisions
Sebastian Bitzer, Stefan J. Kiebel
PDF: http://arxiv.org/pdf/1509.01972v1.pdf
Soundbite: “Our analysis suggests that the brain estimates the reliability of the stimulus on a short time scale of at most a few hundred milliseconds.”

Brain Model of Information Based Exchange
James Kozloski
PDF: http://arxiv.org/pdf/1509.02580v1.pdf
Coolness: IBM Neural Tissue Simulator (about NTS | NTS slides | 1st article)

Interplay between the local information based behavioral responses and the epidemic spreading in complex networks
Can Liu, Jia-Rong Xie, Han-Shuang Chen, Hai-Feng Zhang, Ming Tang
PDF: http://arxiv.org/pdf/1509.01321v1.pdf
Soundbite: “The spreading of an infectious disease can trigger human behavior responses to the disease, which in turn plays a crucial role on the spreading of epidemic…. Our finding indicates that, with the increasing of the response rate, the epidemic threshold is enhanced and the prevalence of epidemic is reduced.”

Identification and modeling of discoverers in online social systems
Matus Medo, Manuel S. Mariani, An Zeng, Yi-Cheng Zhang
PDF: http://arxiv.org/pdf/1509.01477v1.pdf
Soundbite: “We develop an analytical time-aware framework which shows that when individuals make choices — which item to buy, for example — in online social systems, a small fraction of them is consistently successful in discovering popular items long before they actually become popular. We argue that these users, whom we refer to as discoverers, are fundamentally different from the previously known opinion leaders, influentials, and innovators.”

Time-aware Analysis and Ranking of Lurkers in Social Networks
Andrea Tagarelli, Roberto Interdonato
PDF: http://arxiv.org/pdf/1509.02030v1.pdf
Soundbite: “Our goal in this work is to push forward research in lurker mining in a twofold manner: (i) to provide an in-depth analysis of temporal aspects that aims to unveil the behavior of lurkers and their relations with other users, and (ii) to enhance existing methods for ranking lurkers by integrating different time-aware properties concerning information-production and information-consumption actions.”

UofM Student Research on 3D Everything (Except Printing)

#mlibres Students on #3d

Last week there was another of the wonderful Emergent Research Series of lectures sponsored by the University of Michigan Libraries Research Unit (2014 archive, 2013 archive).

Main topics covered were spatial tracking, 3d virtual reality, optical motion capture, holography, optical tracking, acoustic motion tracking. During the Q&A, a major diversion (at least for me) was “Sim-sickness”, in which 3d immersive virtual reality (think of Oculus Rift & Google Cardboard) make folk nauseous, some to the point of actually tossing their cookies. There are videos in Youtube. I don’t need to find them for you. Fun topics mentioned included virtual augmented reality, Hololens, holography for teaching anatomy, biomechanics, cultural preservation, robotics, aerospace engineering, body slicing with the Kinect, body tracking, and DIY arduino acoustic sensors and automated echolocation. There were lots of tips and tricks, what works and what doesn’t. Many interesting links in the Storify below.

What Patients Think About Clinical Trials, Take 2 (#bioethx)

At the Doctor's Office: Push For Help

ADDENDUM

Within minutes after the previous post went live, I was contacted on Twitter by another patient advocate, Willow, also known as Serious Skeptic. She* expressed another wide area of patient concerns about clinical trials, ones that were new to me, and which deserve representation in this post, even if they aren’t from the official public #PatientChat event. Because Willow has a locked account, and I respect that, I asked her permission to share the links and the essence of some of her private tweets. The following is posted with her consent, but represents my words and distillation of what I learned from her.

Willow was concerned about ethical breaches in clinical trials, especially:
– trials that are designed specifically to promote use of a drug (marketing);
– trials that suppress undesired findings or which fail to publish or share negative findings;
– trials that don’t share their data;
– trials that don’t make relevant or useful findings available to all trial participants.

I had the impression she’d kind of like the research studies to also notify trial participants of publications that do result from their participation. I know, I do, myself, and being a medical librarian, I take notes on my research participation, the names of studies, the names of the PI, and I stalk their publications for years until I see the research in which I participated. I often ask to be alerted, and usually received some sort of polite demurral, and nothing else. I wish they had an email list I could just subscribe to for alerts from their lab.

Anyway, when Willow described clinical trials that are actually marketing ruses, my reaction was, “Whoa! Not really? Doesn’t the IRB process protect against that?” Evidently not. The concept she was describing most is called seeding trials. Here are some links she shared with me, or quotes and/or resources from those articles.


A physician is invited by a pharmaceutical company to take part in a study involving an FDA-approved drug. The physician’s responsibilities entail prescribing the drug for patients and then completing three questionnaires about each patient’s experience with the drug. The questionnaires are quite short and will take about 20 minutes each to complete. The sponsor will pay $1,500 for each completed questionnaire. The physician is very interested in participating because it looks like a great way to increase practice revenues.

Rusczek JP, Rusczek AM. Fraud and Abuse in Clinical Research: Three Case Studies. ABA Health eSource June 2010 6(10). American Bar Association. http://www.americanbar.org/content/newsletter/publications/aba_health_esource_home/Rusczek.html
– Research Involving Non-Employed Physician Investigators
– Marketing Disguised as Research
– Double Billing

The public has lacked convincing documentary evidence of a long-suspected drug company practice: promoting a new drug by sponsoring a randomized trial in which participating physicians use the drug as they follow the trial protocol. This practice—a seeding trial—is marketing in the guise of science. The apparent purpose is to test a hypothesis. The true purpose is to get physicians in the habit of prescribing a new drug.

Sox HC. Seeding Trials: Just Say “No.” Ann Intern Med. 2008;149(4):279-280. doi:10.7326/0003-4819-149-4-200808190-00012 http://annals.org/article.aspx?articleid=742309

Seeding trials are designed to appear as if they answer a scientific question but primarily fulfill marketing objectives. Kessler and colleagues (3) portrayed seeding trials as “attempts to entice doctors to prescribe a new drug being marketed by the company” while the company puts its product in the hands of practicing physicians, hoping that the experience of treating patients with the study drug and a pleasant, even profitable, interaction with the company will result in more loyal physicians who prescribe the drug (4).

Hill KP, Ross JS, Egilman DS, Krumholz HM. The ADVANTAGE Seeding Trial: A Review of Internal Documents. Ann Intern Med. 2008;149:251-258. https://www.leg.bc.ca/cmt/39thparl/session-4/health/submissions/Hill_The_Advantage_Seeding_Trial_2008.pdf

“Merck’s marketing division handled both the scientific and the marketing data, including collection, analysis, and dissemination; and Merck hid the marketing nature of the trial from participants, physician investigators, and institutional review board members.”

Keim B. Merck Vioxx Study Disguised Marketing as Science. Wired 08.19.08 1:22 PM. http://www.wired.com/2008/08/merck-vioxx-stu/

Merck minimized the true risks of Vioxx (Apr 17, 2008) https://www.youtube.com/watch?v=PQYxZSUDnqI

The maker of Neurontin disguised an effort to promote the anti-seizure drug to physicians as a clinical trial and failed to inform involved physicians and patients, according to a new analysis published Monday in the Archives of Internal Medicine journal.

Girion L. Neurontin study was a sham designed to boost drug sales, researchers say in medical journal. Los Angeles Times June 27, 2011. http://articles.latimes.com/2011/jun/27/news/la-heb-neuronton-seeding-trial-20110627

Seeding trials are an unethical, dangerous way to market a product. The IRB needs to become a better-equipped committee that can identify seeding trial practices from honest clinical trials, and the FDA needs to demand more transparency from companies sponsoring clinical trials, to better protect public health and the integrity of clinical research.

Varga M. Are Seeding Trials Ethical? Kulkarni Law Firm Blog June 11, 2012 11:11. https://www.conformlaw.com/blog/are-seeding-trials-ethical/

Recommended Principles to Guide Academy-Industry Relationships. American Association of University Professors. University of Illinois Press, Jan 25, 2014. See the endnotes on pages 341-2. https://books.google.com/books?id=lFSNAgAAQBAJ&pg=PA341&lpg=PA341&dq=drug+seeding+trials&source=bl&ots=AEZ1Xa7NUS&sig=W_nCm_h2w7Uhtf5tWd4V6sf5ggI&hl=en&sa=X&ved=0CDIQ6AEwAzgeahUKEwjw9JWVyovGAhWjWowKHTvgAJQ#v=onepage&q=drug%20seeding%20trials&f=false


Because of the risks and distrust generated by the practice of seeding trials, Willow suggested that it might be wiser to wait to test new meds on your own body until they’ve been out for a few years, unless you are so ill that you have no alternatives. Now, of course, if everyone does that, then there are NO NEW DRUGS because we can’t test them! And that is a situation in which we all lose.

My own choices? I take risks that I won’t ask others to take. I try to be informed about the risks I take. When I participate in a research study, I ask a lot of questions, and I pay very close attention to my body. If my canary-in-the-mine body complains, I withdraw from the study. Well, I would. So far, I’ve never actually needed to withdraw from a research study, but I have ceased taking actual FDA-approved meds prescribed for me that my body couldn’t handle. I’m hoping that the #bioethx chat group will pick up on this topic next, and hoping they can find an invited speaker to talk about what IRB committees have done and are doing to try to address this, to build confidence in medical research.


* I am assuming Willow is a she because I interpret the name Willow as a female name. I have no knowledge or confirmation of that, and it isn’t any of my business anyway. I am using the female pronoun to describe her simply for convenience, and intend no disrespect.


ADDENDUM TWO, June 13

A few clarifications and corrections from the ever thoughtful Willow.

Willow feels my concern about limiting drug discovery isn’t valid, since seeding trial occur for drugs that are already patented. My concern is that fear of seeding trials will scare some participants off of drug trials entirely. Drug discovery trials are legitimate, but the problem remains that it can be difficult to distinguish discovery trials from seeding trials, since the physicians and patients are both kept in the dark by the drug manufacturers.

Informed Consent in a New Era

Informed Consent copy

I’m a big fan of John Wilbanks’ work in the area of open personal health data and informed consent, and have blogged about that here before. Briefly, my awareness of John’s work began with “We Consent” which has now transformed into Sage’s “Participant Centered Consent Toolkit.”

Cool Toys Pic of the day - We Consent
Sage: Participant-Centered Consent Toolkit (E-Consent)

Recently someone asked me a question about “online informed consent.” I think they were remembering my having mentioned John Wilkin’s stuff, a.k.a “portable legal consent” or “portable informed consent.” These and “online informed consent” are … related concepts, but perhaps not as closely related as some might think. Just to complicate matters, people are also using jargon like “dynamic consent” and “broad consent” to mean things related to both of these, but which are not quite the same. There are also people trying to get the phrase “informed consent” converted to “educated consent” as possibly being more meaningful. In this post, I will try to sort some of this out, but I’m no kind of expert in consent, and this is complicated, really REALLY complicated.

First, the short-short explanation. Portable informed consent (PIC) usually is part of online informed consent, but online informed consent (OIC) is rarely portable. Riiiight. OK, a step backwards.

PORTABLE CONSENT

The idea of portable informed consent is (in my mind, at least) analogous to Creative Commons licensing for your own creative works, except that it applies to your own health data. Actually, the idea of this really came from people wanting to share genomic data. You walk through an online informed consent process, agree to which version of a license you are comfortable with, and then when you share your data in a secure repository, that license or consent agreement is attached. People who want to use your data, must agree to follow those predetermined restrictions. Researchers who don’t agree, aren’t allowed to see your data, only data from other folk who agree to whatever guidelines they need for their project. Researchers who don’t follow the rules will be denied access to all of the data.

Personal Genomics

Genomics is basically mapping the genome. Personal genomics is doing this for a person in particular, rather than a species or condition or other collective group. Some people get involved in exploring personal genomics because of simple curiosity, but many are driven by long standing medical challenges without any easily identifiable solution. Some people are terrified at the idea of what they might find out. Others are concerned that the data will result in problems with jobs or insurance. Those urgently seeking help for health problems often want to share and find others who might have insights into their problem. OpenSNP and the Personal Genome Project are two examples of places where people share their genomic data. By making their data public and consenting to its use by researchers, they are hoping to support solutions not only for themselves but for others like them. Making sure that consent is LEGAL is essential for supporting future research. One great example of this is Jay Lake, who contributed his whole DNA sequencing data and that of his tumor, making possible research on new treatments that came too late for him. It’s a powerful story.

ONLINE INFORMED CONSENT

Online informed consent is a great deal simpler, in that it mostly takes the usual informed consent process (reading forms, signing forms, filing forms) and puts it all into an online web-based interface in a secure system. But, PIC gets more buzz in the popular press and media, while OIC gets more attention from within the hallways of day-to-day research communities. PIC grew out of work with personal genomics and is designed to make data sharing simpler, research more open, and problem solving more dynamic, all while still being responsive to issues of privacy and ethics. OIC is a tool designed to make the IRB management simpler for researchers.

DYNAMIC CONSENT

Dynamic consent is closer to portable consent, but grew more out of tissue and biobanking contexts, rather than data or genomics. Dynamic consent has a lot of nitpicky little options, and allows you to change your mind over time. That’s why it’s dynamic — things keep changing. Right now, dynamic consent is used primarily for what happens to parts of your body that are removed from your body while you are alive, and used for various medical purposes. Sometimes those purposes involved throwing what wasn’t used in the nearest incinerator, but sometimes there is something interesting and the doctors or researchers want to keep a sample for future use.

Biobanking

Now, remember, I’m drastically oversimplifying here. There are many more situations and options that come into play. Healthcare researchers have come to realize that we often don’t know where the next interesting possibility will come from, which is part of why biobanking is becoming more important. A biobank is sort of a library of tissues (meaning parts of human or animals or plants). Biobanks are often focused on a certain type of tissue or condition. Many biobanks collect tissues for a particular kind of cancer, or conditions like Parkinson’s, Alzheimer, autism, etc. Others may focus on a particular organ, like brains, breast tissue, lungs, or genome. In book and journal libraries, the librarians have traditionally spent a lot of time trying to select just the most important material on their special topics, but over generations, we’ve found the most desired content is as often as not the parts that were considered cheap and unimportant at the time, which are now expensive and hard to find, because no one kept them. Some of the same issues are coming up with biobanking, but complicated by the challenge of each and every sample being unique (although there might be copies of cell lines). At least with books, if one library lost theirs, another library might have a copy. Part of the idea of all these different kinds of consent is to try to maximise the number and diversity of samples that can be preserved and made accessible to future researchers.

PRESUMED CONSENT

Presumed consent also related to tissues, actually organ donation, but after you are no longer alive or aware enough to give or change your consent. Where I live, you have to register as an organ donor. If you don’t, and are in a fatal accident, no one is allowed to use your organs as transplants to save the lives of other folk who need new organs to survive. That isn’t how it works in all countries, though. In some countries they have “presumed consent,” where the assumption is that organ donation is fine with you as long as you don’t say NO beforehand. So, opt-in vs. opt-out. That’s the main difference. Sounds simple, doesn’t it? But people have incredibly strong feelings about both of these options.

BROAD CONSENT

Broad consent is probably the messiest of all of these. Just look at these article titles!

Can Broad Consent be Informed Consent?

Broad consent is informed consent

Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?

Broad Consent Versus Dynamic Consent: Pros And Cons For Biobankers To Consider

Broad Consent in Biobanking: Reflections on Seemingly Insurmountable Dilemmas

Should donors be allowed to give broad consent to future biobank research?

You can just feel the tensions rising as you read through the list. It is obvious that this is not an area of consensus. And what can it possibly mean to consent mean when there isn’t an agreement about what consent is?

“Broad consents are not open nor are blanket consents. To give a broad consent means consenting to a framework for future research of certain types.” Steinsbekk KS, Myskja BK, Solberg B. Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem? European Journal of Human Genetics (2013) 21:897–902.

Broad consent attempts to make a best guess of what might be needed by the researcher of the future, and to try to get the individual to agree to a flexible use and reuse of tissues, samples, or data. As you can tell from the titles above, “broad consent” tends to refer to tissues rather than data, but when you get down to brass tacks, all of these could theoretically apply to a wide variety of donated content.

CLOSING THOUGHTS

The idea behind all of these myriad forms of consent is knotted into the dynamic between the rights of the individual and the needs of the community. Without research, we stagnate and die, literally, since solutions cannot be discovered for the aches and pains and problems that lead to increased mortality and reduced longevity. As a community, as a species, we don’t make progress without sharing. At the same time, the goal is to reduce harm to individuals, and forcing people to ‘consent’ against their will causes harm. I’ve known people who practically had a nervous breakdown at the idea of becoming an organ donor, the idea of part of them living on in someone else distressed them that deeply. I know others who fear what could happen to them if their genetic data fell into the “wrong hands.” I’m not one of them. I’m a registered organ donor, and I donated my genomic data to OpenSNP. But I still respect the emotional pain that would be caused by forcing consent. It’s an ethical dilemma which our society is obviously still working to solve. While looking at background material for this post I stumbled across two phrases that seemed to express some of the challenges well: “From Informed Consent to No Consent?” “Open Consent for Closed Minds.”

“I’m proposing … that we reach into our bodies and we grab the genotype, and we reach into the medical system and we grab our records, and we use it to build something together.” “I hate [the] word ‘patient.’ I don’t like being patient when … health care is broken.” John Wilbanks